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NRAC Issue #2091 March 2, 2016 21 Pages

NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION

THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC

SUMMARY PAGE

MEDICAL DEVICES PRODUCT Auto Endo5 Hem-o-lok Automatic Clip Applier MANUFACTURER Teleflex Medical PAGE 17 PRODUCT Birmingham Hip Resurfacing (BHR) System MANUFACTURER Smith & Nephew Inc PAGE 16 PRODUCT BladderScan® BVI 9600 and AortaScan® AMI 9700 MANUFACTURER Verathon Inc PAGE 6 PRODUCT BrightView Gamma Cameras MANUFACTURER Philips Medical Systems (Cleveland) Inc PAGE 11 PRODUCT CARDIOSAVE Hybrid Intra-Aortic Ballon Pump (IABP) MANUFACTURER Maquet PAGE 16 PRODUCT ClosureFast Micro Introducer Sheath Sets MANUFACTURER Argon Medical Devices Inc PAGE 11 PRODUCT Custom Perfusion Tubing Pack MANUFACTURER Medtronic Perfusion Systems PAGE 4 PRODUCT DEFENDO suction valves MANUFACTURER Medivators Inc PAGE 16 PRODUCT Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer MANUFACTURER Siemens Healthcare Diagnostics, Inc PAGE 19 PRODUCT EndoVive 3s Low Profile Balloon Kits MANUFACTURER Xeridiem Mediem Medical Devices Inc PAGE 19 PRODUCT Flexor Check-Flo Introducer MANUFACTURER Cook Inc PAGE 19 PRODUCT GEMflex Coil, 3.0T, used with GE Healthcare 3.0T Scanners

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MANUFACTURER NeoCoil PAGE 16 PRODUCT Helioseal Clear Refill 1 x 1.25g MANUFACTURER Ivoclar Vivadent, Inc PAGE 17 PRODUCT HipLOC CHS Plate/Lag Screw Introducer MANUFACTURER Biomet, Inc PAGE 19 PRODUCT Karma Flexx Wheelchair MANUFACTURER Karman Healthcare Inc PAGE 18 PRODUCT Kopans Breast Lesion Localization Needle MANUFACTURER Cook Inc PAGE 18 PRODUCT Mammomat Inspiration with Tomosynthesis functionality MANUFACTURER Siemens Medical Solutions USA, Inc PAGE 14 PRODUCT Multicompartmental Knee (MCK) System MANUFACTURER Mako Surgical Corp PAGE 18 PRODUCT Naturalyte Liquid Acid Concentrate MANUFACTURER Fresenius Medical Care Renal Therapies Group, LLC PAGE 17 PRODUCT Olympus, flexible scope, large diameter MANUFACTURER Integrated Medical Systems Inc PAGE 6 PRODUCT Paper Chart Recorder, PRN 50M+ MANUFACTURER GSI Group Inc PAGE 11 PRODUCT Precision MPi x-ray system MANUFACTURER Regulatory Insight, Inc PAGE 18 PRODUCT Quadrox-i Oxygenators, etc MANUFACTURER Maquet Medical Systems PAGE 15 PRODUCT Quick Connect MANUFACTURER STERIS Corp PAGE 17 PRODUCT T2 K-Wire 1.8 x 310 mm, etc MANUFACTURER Stryker Howmedica Osteonics Corp PAGE 3

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PRODUCT TLC Self-Retaining Retractor Frames, etc MANUFACTURER Applied Medical Technology, Inc PAGE 14 PRODUCT Virage OCT Spinal Fixation System: Surgical Technique Manual MANUFACTURER Zimmer Spine, Inc PAGE 4

PHARMACEUTICALS PRODUCT Menthocin Patch with Lidocaine-Strong MANUFACTURER Bonita Pharmaceuticals, LLC PAGE 21 PRODUCT Minocycline Hydrochloride MANUFACTURER AvKARE, Inc PAGE 21 PRODUCT Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders) MANUFACTURER Medical Park Homecare, Inc PAGE 21 PRODUCT Paricalcitol Capsules MANUFACTURER Dr Reddy's Laboratories, Inc PAGE 20 PRODUCT Sulfameth+Trimeth Tab 8C/160 MUT 100@ MANUFACTURER Sun Pharmaceutical Industries Ltd PAGE 21 ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) T2 K-Wire 1.8 x 310 mm, Sterile RECALL NUMBER Z-0867-2016 PRODUCT 2) METAIZEAU Intramedullary Pin, 2.0 x 400 mm RECALL NUMBER Z-0868-2016 PRODUCT 3) Gamma K-Wire 3.2x450 mm RECALL NUMBER Z-0869-2016 PRODUCT 4) Gamma K-Wire 3.2x450 mm, UNS-Thread RECALL NUMBER Z-0870-2016 PRODUCT 5) Gamma Guide Pin, 4x400 mm RECALL NUMBER Z-0871-2016 PRODUCT 6) Gamma3 K-Wire with Washer, 13x3.2x500 mm RECALL NUMBER Z-0872-2016 PRODUCT 7) T2 K-Wire, 3x285 mm RECALL NUMBER Z-0873-2016 PRODUCT 8) T2 K-Wire with washer, 7.8 x 3 x 285mm RECALL NUMBER Z-0874-2016 PRODUCT 9) T2 Guidewire, Ball-Tipped, 3x800 mm RECALL NUMBER Z-0875-2016 PRODUCT 10) T2 Guidewire, Ball-Tipped, 2.5x800 mm RECALL NUMBER Z-0876-2016 PRODUCT 11) T2 Guidewire, Ball-Tipped, 2.5 x 1000mm RECALL NUMBER Z-0877-2016 PRODUCT 12) T2 Guidewire, Ball-Tipped, 3 x 1000mm

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RECALL NUMBER Z-0878-2016 PRODUCT 13) T2 Guidewire, Smooth-Tipped, 3 x 800mm RECALL NUMBER Z-0879-2016 PRODUCT 14) T2 Guidewire, Smooth-Tipped, 2.2 x 800mm RECALL NUMBER Z-0880-2016 PRODUCT 15) T2 Guidewire, Ball Tipped, 3 x 1250mm RECALL NUMBER Z-0881-2016 PRODUCT 16) T2 Fixation K-Wire 3 x 285mm WCH coated RECALL NUMBER Z-0882-2016 PRODUCT 17) T2 K-Wire, 3.2x400mm, Recon RECALL NUMBER Z-0883-2016 PRODUCT 18) T2 K-Wire, 3.2x400mm, CoCr, Recon RECALL NUMBER Z-0884-2016 CODE 1) Catalog number 0152-0218S; 2) Catalog number 0190-2000S; 3) Catalog number

12106450S; 4) Catalog number 1210-6451S; 5) Catalog number 1213-9091S; 6) Catalog number 1320-0016S; 7) Catalog number 1806-0050S; 8) Catalog number 1806-0051S; 9) Catalog number 1806-0080S; 10) Catalog number 1806-0083S; 11) Catalog number 1806-0084S; 12) Catalog number 1806-0085S; 13) Catalog number 1806-0090S; 14) Catalog number 1806-0093S; 15) Catalog number 1806-1250S; 16) Catalog number 1806-1417S; 17) Catalog number 1806-3030S; 18) Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life

MANUFACTURED & RECALLED BY Stryker Howmedica Osteonics Corp, Mahwah, NJ QUANTITY 147,838 units in total DISTRIBUTION Nationwide REASON During a review of the packaging, it was determined that the seal integrity of the pouch may

be decreased. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Virage OCT Spinal Fixation System: Surgical Technique Manual RECALL NUMBER Z-1019-2016 CODE L1637 Rev B (2014-06)MANUFACTURED & RECALLED BY Zimmer Spine, Inc, Minneapolis, MN QUANTITY 15,753 DISTRIBUTION Nationwide and internationally REASON Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT

Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Custom Perfusion Tubing Pack, Rx, Sterile EO RECALL NUMBER Z-1023-2016 CODE 3169316867

CB7U79R9 209789343 00643169555518 CB7U79R9 210140699 00643169555518 CB7U79R9 210238180 00643169555518 CB7W53R1 210370420 00643169370951 CB7X82R4 209759901 00643169471986 CB7X82R4 209945892 00643169471986 CB7X88R8 209704289 00643169503489 CB7Z19R12 209809075 00643169632769 CB8A17R1 210140986 00643169591233 CB8G67R4 209673526 00643169639478 CB8G67R5 210093640 00643169662759

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CB8G67R5 210093641 00643169662759 CB8G67R5 210093643 00643169662759 CB8G67R5 210093644 00643169662759 CB8L67R 209857585 00643169511002 CB8L67R 209961591 00643169511002 CB8L67R1 210204050 00643169671324 CB8L68R1 209590561 00643169572928 CB8L68R1 209821242 00643169572928 CB8L68R1 210010536 00643169572928 CB8Q44R2 209890932 00643169654457 CB8Q44R2 210102397 00643169654457 CB8U31R1 20987108 9 00643169625426 HY0L44R20 209948033 00643169513266 HY0Z20R21 209857521 00643169463356 HY0Z20R21 209981152 00643169463356 HY0Z20R21 210238122 00643169463356 HY1C33R26 210010580 00643169462304 HY1C33R26 210238185 00643169462304 HY2800R37 209981429 00643169464803 HY2800R37 210238124 00643169464803 HY2J35R12 209674416 00643169476325 HY2J36R13 209759925 00643169464810 HY2J36R13 210107121 00643169464810 HY2J36R13 210258716 00643169464810 HY2J36R13 210303787 00643169464810 HY2K67R10 209948904 00643169352933 HY2K67R10 210204020 00643169352933 HY2S09R13 209732264 00643169506428 HY2S09R13 210107051 00643169506428 HY2S24R6 209876726 00643169648104 HY3H13R3 210305657 00643169632028 HY3U59R13 209646300 00643169400566 HY3U59R13 210046438 00643169400566 HY3V10R27 209704348 00643169407572 HY3V10R27 210010521 00643169407572 HY5V41R17 209610607 00643169632653 HY5V41R17 209732230 00643169632653 HY5V41R18 209927775 00643169655959 HY5V41R18 210107073 00643169655959 HY6E90R8 209792638 00643169617209 HY6E90R8 209793288 00643169617209 HY6E90R8 210289316 00643169617209 HY6G55R9 209758185 00643169345508 HY6M93R11 210079435 00643169625440 HY6M93R11 210238187 00643169625440 HY6M93R11 210410712 00643169625440 HY6N63R10 209704334 00643169518285 HY6N63R10 209857569 00643169518285 HY6N63R10 210107099 00643169518285 HY6W12R9 209646254 00643169533981 HY6W12R9 209981438 00643169533981 HY6Y19R5 209641911 00643169510432 HY6Y19R5 209893091 00643169510432 HY6Y19R5 209981566 00643169510432 HY7B90R7 210305642 00643169625457

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HY7G56R8 209774222 00643169647152 HY7G56R8 209857577 00643169647152 HY7G56R8 210174904 00643169647152 HY7M47R7 209704333 00643169485273 HY7M47R7 209981461 00643169485273 HY7N09R8 209784772 00643169478688 HY7R78R5 209821150 00643169625464 HY7S09R6 210341788 00643169617216 HY7V67R8 210204122 00643169633315 HY7V82R9 210138303 00643169666603 HY7V82R9 210138304 00643169666603 HY7X48R10 210274824 00643169692145 HY7X48R8 209922894 00643169559721

HY7Z58R6 209922879 00643169554320 HY8L14R4 209789318 00643169555471 HY8L14R4 209999104 00643169555471 HY8M65R1 209641913 00643169541191 HY8M65R1 20982124 3 00643169541191 HY8M65R2 210046295 00643169661295 HY8N22R6 209674428 00643169582910 HY8N22R8 209981444 00643169650749 HY8R55R 209948419 00643169584655 HY8R66R3 209753350 0064316958

MANUFACTURED & RECALLED BY Medtronic Perfusion Systems, Brooklyn Park, MN QUANTITY 7773 DISTRIBUTION Nationwide and internationally REASON Medtronic is notifying customers who have or may receive specific lots of Medtronic

Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS).

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT BladderScan® BVI 9600 and AortaScan® AMI 9700 RECALL NUMBER Safety notice CODE Model numbers 0270-0451, 0270-0452, 0270-0754, U270-0451, 0270-0636, 0270-0639,

U270-0636; all serial numbers MANUFACTURED & RECALLED BY Verathon Inc, Bothell, WA QUANTITY BVI 9600: 1650, AMI 9700: 873 DISTRIBUTION Nationwide REASON The devices are not indicated for use as a screening or diagnostic tool to detect abdominal

aneurysms (AAAs). ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) Olympus, flexible scope, large diameter, video pediatric colonoscope RECALL NUMBER Z-0889-2016 PRODUCT 2) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0890-2016 PRODUCT 3) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0891-2016 PRODUCT 4) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0892-2016 PRODUCT 5) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0893-2016 PRODUCT 6) Olympus, flexible scope, large diameter, video gastroscope

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RECALL NUMBER Z-0894-2016 PRODUCT 7) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0895-2016 PRODUCT 8) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0896-2016 PRODUCT 9) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0897-2016 PRODUCT 10) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0898-2016 PRODUCT 11) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0899-2016 PRODUCT 12) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0900-2016 PRODUCT 13) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0901-2016 PRODUCT 14) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0902-2016 PRODUCT 15) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0903-2016 PRODUCT 16) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0904-2016 PRODUCT 17) Olympus, flexible scope, large diameter, video duodenoscope RECALL NUMBER Z-0905-2016 PRODUCT 18) Olympus, flexible scope, large diameter, video gastroscope RECALL NUMBER Z-0906-2016 PRODUCT 19) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0907-2016 PRODUCT 20) Olympus, flexible scope, large diameter, video pediatric colonoscope RECALL NUMBER Z-0908-2016 PRODUCT 21) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0909-2016 PRODUCT 22) Olympus, flexible scope, large diameter, video colonoscope RECALL NUMBER Z-0910-2016 CODE 1) Model No PCF-H180AL – serial numbers:

2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573,2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496,2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345,2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811,2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648,2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090,2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718,2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876,2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517,2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274,2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648,2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029,2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793,2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654,2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701,2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345,2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769,2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632,2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343 2) Model No GIF-H180 – serial numbers:

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2003035,2704738,2704724,2809007,2808939,2105965,2808765,2004365,2004669,2902353,2902347,2902342,2004663,2602122,2105267,2601317,2806231,2805648,2808714,2807053,2807205,2705548,2806959,2704571,2704560,2704611,2705574,2805740,2004809,2703149,2601037,2901878,2702879,2702870,2703000,2704441,2902854,2003990,2003988,2705078,2004004,2702967,2808478,2809057,2601256,2601255,2808955,2808944,2807181,2809202,2206863,2900222,2900226,2900745,2901670,2900229,2003063,2902820,2002897,2600226,2602014,2003460,2900362,2900112,2806936,2003147,270517S,2704934,2909893,2909872,2909863,2901323,2806640,2704259,2106188,2106273,2601745,2704573,2003712,2807584,2807557,2807713,2106293,2106290,2106303,2106300,2807679,2704771,2704770,2704792,2704800,2602187,2704885,2808319,2602175,2808317,2602190,2702863,2808937,2809103,2901274,2002984,2002916,2901389,2901374,2601611,2805999,2004421,2704766,2703778,2705367,2795393,2805917,2805916,2809093,2902295,2004720,2902215,2809055,2004871,2705449,2809016,2809050,2808936,2808938,2805816,2809044,2900211,2901687,2601179,2602413,2704897,2705037,2808546,2808581,2808537,2808530,2004462,2004461,2004458,2004457,2004452,2900338,2806650,2900337,2704236,2704202,2806696,2902604,2703089,2601468,2004949,2702732,2602089,2808410,2808402,2808413,2808391,2808412,2808415,2808405,2808379,2807126,2705106,2805727,2702820,2705110,2702954,2704316,2103301,2901080,2901329,2901326,2900094,2807461,2807463,2600468,2600432,2600183,2003532,2602342,2901759,2901798,2901789,2901786,2004023,2004047,2601355,2206691,2807571,2601721,2900252,2808516,2809385,2809049,2809068,2809056,2809060,2806692,2806772,2702822,2807586,2703753,2106008,2902452,2704036,2601438,2703138,2601515,2703127,2703134,2105807,2806871,2806863,2003144,2902409,2806880,2809409,2703670,2900905,2900885,2900901,2900907,2900902,2900892,2902465,2105610,2600472,2602482,2004043,2909906,2808548,2602237,2901669,2900507,2705345,2703372,2600645,2003099,2807855,2806888,2807784,2807852,2704075,2900761,2806646,2900595,2809208,2902564,2600735,2003799,2601893,2602481,2003728,2003726,2900894,2808085,2808064,2808060,2900874,2003167,2105243,2909945,2601918,2809264,2909796,2909798,2004189,2704407,2901872,2808189,2808188,2600417 3) Model No CF-H180AL – serial numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849,2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559,2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038,2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580,2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007,2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009,2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560,2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106,2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163,2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263,2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653,2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241,2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493,2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544,2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272,2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750,2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937,2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343,2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051,2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017,2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654,2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046,2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850,2805888,2309542 4) Model No GIF-160 – serial numbers: 2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,200128

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5,2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035,2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538,2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057,2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441,2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047,2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371,2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161,2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745,2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274,2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800,2307470 5) Model No GIF-H180J – serial numbers: 2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252,2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716,2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040,2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241,2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216,2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514,2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746,2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768,2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479,2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228,2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098,2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606,2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120,2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960,2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574,2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713,2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783,2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731 6) Model No GIF-Q180 – serial numbers: 2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458,2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413,2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694,2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869,2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697,2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935,2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687,2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354,2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176,2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386,2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738,2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064,2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316,2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053,2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067,2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964,2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374,2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576,2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059 7) Model No GIF-XP160 – serial numbers: 2000023,2110370,2211004,2210975,2110666,2110583,2411739,22109S9,2311220,2812668,2311177,2110498,2411568,2110745,2110711,2000181,2211040,2812506,2110504,23113

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72,2012921 8) Model No CF-Q180AL – serial numbers: 2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253, 2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826, 2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251, 2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935, 2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143, 2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372, 2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206, 2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287, 2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592, 2500217 9) Model No PCF-160AL – serial numbers: 2123053,2337714,2338700,2337727,2112612 10) Model No CF-Q160L – serial numbers: 2000158,2203109,2000413,2101113,2304140,2203874,2405424,2203295,2203853, 2517622,2101047,2102290,2102302,2102305,2102303,2203697,2102317,2102297, 2202898,2203059,2203471,2304922,2202617,2416261,2102141,2101633 11) Model No GIF-Q140 – serial numbers: 2813102,2914792,2711389,2711291,2812266,2812356,2802476,2600371,2914632, 2914333 12) Model No GIF-140 – serial numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325 13) Model No PCF-Q180AL – serial numbers: 2707306,2705876,2807674,2706579,2009538,2706717,2604531,2706710,2501499, 2808113,2705777,2705730,2707016,2808779,2808777,2707125,2603799,2603795, 2603779,2603825,2604265,2807420,2604568,2501361,2500180,2602289,2909274, 2808355,2808217,2808957,2808020,2602290,2707346,2707406,2808556,2807468, 2603295,2604460,2705711,2009462,2602564,2501493,2808528,2500150,2603952, 2603243,2807523,2500982,2500983,2706852,2706892,2009425,2500420,2501392, 2603200,2807685,2501550,2501315,2706332,2604191,2604217,2706407,2603757, 2603028,2603031,2501324,2300253,2300252,2603975,2704883,2603976,2807640, 2808342,2707351,2602872,2808599,2706811,2707210,2500216,2501543,2808299, 2808816,2100010,2807695,2009697,2500686,2604024,2705191,2808911,2808139, 2602993,2705168,2500369,2500602,2501796,2705522,2009502,2808909,2808836, 2601829,2601832,2807758,2707152,2808449,2501699,2601820,2501213,2200069, 2808356,2704854,2704864,2603401,2704735,2603647,2705203,2808490,2501463, 2602027,2705832,2501166,2603137,2603106 14) Model No CF-Q160AL – serial numbers: 2427253,2528563,2315445,2314847,2212887,2315826,2000027,2314864,2315955, 2213834,2212872,2315727,2315729,2213866,2416648,2427952,2416195,2314929, 2111326,2416125,2213186,2111744,2315611,2213344,2314241,2427731,2427747, 2314885,2314876,2314596,2010689,2314038,2315864,2010526,2315138,2315140, 2315540,2111669,2212839,2212640,2427816,2314895,2427562 15) Model No CF-140L – serial numbers: 2127866,2712435,2914674,2026893,2916216,2813792,2228261,2711888,2600329 16) Model No GIF-Q160 – serial numbers: 2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971, 2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100, 2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556, 2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217, 2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785, 2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258 17) Model No TJF-160F – serial numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061,

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2201491,2000039,2100930,2402518,2302084,2100852,2101121 18) Model No GIF-XQ140 – serial numbers: 2600297,2601232,2600397,2013906 19) Model No PCF-140L – serial numbers: 2700328,2912416,2811408 20) Model No PCF-H190L – serial number: 2303917 21) Model No CF-Q140L – serial numbers: 2913081,2600279 22) Model No XCF-Q160ALE – serial number: 240T024

MANUFACTURED & RECALLED BY Integrated Medical Systems Inc, Birmingham, AL QUANTITY 1) 190, 2) 275, 3) 232, 4) 111, 5) 180, 6) 185, 7) 21, 8) 82, 9) 5, 10) 26, 11) 9, 12) 12, 13)

122, 14) 43, 15) 9, 16) 54, 17) 16, 18) 4, 19) 3, 20) 1, 21) 2, 22) 1 DISTRIBUTION Nationwide and internationally REASON If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe

assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Paper Chart Recorder, PRN 50M+ RECALL NUMBER Z-0866-2016 CODE GE part number 2062759-001, manufacturer part number 600-23310-01, serial number

range 1801405 through 1918761 MANUFACTURED & RECALLED BY GSI Group Inc, Bedford, MA QUANTITY 2257 units DISTRIBUTION Nationwide and internationally REASON The item was recalled due to an increased user/patient risk of exposure to fire and/or

electrical shock due to the failure of the PRN 50-M+ Digital Writer. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT ClosureFast Micro Introducer Sheath Sets RECALL NUMBER Z-1029-2016 CODE Model number MIS-7F07, lot number 11125585; model number IS-7F11, lot number

11126021; Bundle Order Numbers, Contents: CPK50-11, CLF7-7-60/CFP Procedure Pack/IS-7Fll; CPK51-11, CLF7-7-60/CFP Procedure Pack/IS-7Fll; CPK54-07, CLF7-7-60/CFP Procedure Pack/MIS-7F07; CPK55-07, CLF7-7-60/CFP Procedure Pack/MIS-7F07; CPK64-07, CLF7-7-60/No Pack/MlS-7F07; CPK65-07, CLF7-7-60/NO Pack/MIS-7F07; CPK68-11, CLF7-7-60/NO Pack/IS-7Fll; CPK82-11, CLF7-3-60/ CFP Procedure Pack/IS-7Fll; CPK83-07, CF7-3-60/ CFP Procedure Pack/MI$-7F07; CPK84-11, CF7-3-60/No Pack/IS-7Fll; CPK85-07, CF7-3-60/No Pack/MIS-7F07

MANUFACTURED Argon Medical Devices Inc, Athens, TX RECALLED BY Medtronic, Mounds View, MN QUANTITY 2000 units DISTRIBUTION Nationwide REASON The Micro Introducer Sheath Sets may have an 11 cm length introducer sheath in the 7 cm

package, or the Introducer Sheath Sets may have a 7 cm introducer sheath in an 11 cm package. Affected Introducer Sheath sets are by itself or part of a bundle order (may be referred to as a kit).

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) BrightView Gamma Cameras RECALL NUMBER Z-1020-2016 PRODUCT 2) BrightView X Gamma Cameras RECALL NUMBER Z-1021-2016 PRODUCT 3) BrightView XCT & BrightView XCT Upgrade RECALL NUMBER Z-1022-2016

12

CODE 1) Model #882480; Serial #'s: 4000002, 4000002.75, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065, 4000066, 4000068, 4000070, 4000071, 4000072, 4000073, 4000074, 4000075, 4000076, 4000077, 4000078, 4000079, 4000080, 4000081, 4000082, 4000083, 4000086, 4000087, 4000088, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000096, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120, 4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000134, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000163, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000196, 4000197, 4000198, 4000199, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000211, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278, 4000279, 4000280, 4000281, 4000282, 4000283, 4000284, 4000285, 4000286, 4000287, 4000288, 4000289, 4000290, 4000291, 4000292, 4000293, 4000294, 4000295, 4000296, 4000297, 4000298, 4000299, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 4000332, 4000333, 4000334, 4000335, 4000336, 4000337, 4000338, 4000339, 4000340, 4000341, 4000342, 4000343, 4000344, 4000345, 4000346, 4000347, 4000348, 4000349, 4000351, 4000352, 4000353, 4000354, 4000355, 4000356, 4000357, 4000358, 4000359, 4000360, 4000361, 4000362, 4000363, 4000364, 4000366, 4000367, 4000368, 4000369, 4000370, 4000371, 4000372, 4000373, 4000374, 4000375, 4000376, 4000377, 4000378, 4000379, 4000380, 4000381, 4000382, 4000383, 4000384, 4000385, 4000386, 4000387, 4000388, 4000389, 4000390, 4000391, 4000392, 4000394, 4000395, 4000396, 4000397, 4000398, 4000399, 4000400, 4000401, 4000402, 4000403, 4000404, 4000405, 4000406, 4000407, 4000408, 4000409, 4000410, 4000411, 4000412, 4000414, 4000415, 4000416, 4000417, 4000418, 4000419, 4000420, 4000421, 4000422, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000431, 4000432, 4000433, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000465, 4000466, 4000467, 4000468, 4000469, 4000470, 4000471, 4000473, 4000474, 4000475, 4000476, 4000477, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000484, 4000485, 4000486, 4000487; 2) Model #882478; Serial #'s: 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045,

13

11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000081, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340001, 11340002, 11340003, 11340004, 11340005, 11000015; 3) Model #882482; Serial #'s: 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000068, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000075, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000112, 6000113, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000207, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000261, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271, 6000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000289, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000301, 6000302, 6000303, 6000304, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000340, 6000341, 6000342, 6000343, 6000344, 6000345, 6000346, 6000347, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000363, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000374, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000391, 6000392, 6000393, 6000394, 6000395, 6000396, 6000398, 6000399, 6000400, 6000401, 6000402, 6000403, 6000404, 6000405, 6000406, 6000407, 6000408, 6000409, 6000410, 6000411, 6000412, 6000413, 6000414, 6000415, 6000416, 6000417, 6000418, 6000419, 6000420, 6000421, 6000422, 6000423,

14

6000424, 6000425, 6000426, 6000427, 6000428, 6340008, 6340009, 6340010, 6340011, 6000004A, 6000014, 6000039, 6000046, 6000082, 6000163, 6000243, 6000282, 6000006A

MANUFACTURED & RECALLED BY Philips Medical Systems (Cleveland) Inc, Cleveland, OH QUANTITY 1) 677 units, 2) 117 units, 3) 427 units DISTRIBUTION Nationwide and internationally REASON During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution

(CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Also, during a scan, the gantry motion may halt prematurely.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Mammomat Inspiration with Tomosynthesis functionality RECALL NUMBER Z-0888-2016 CODE Model number: 10140000MANUFACTURED & RECALLED BY Siemens Medical Solutions USA, Inc, Malvern, PA QUANTITY 76 units DISTRIBUTION Nationwide REASON A potential system fatal error may occur during tomosynthesis reconstruction with large

breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT TLC Self-Retaining Retractor Frames, TLC Self-Retaining Retractor Systems, Wilson

Penile Implantation Systems, Wilson Implantation Systems RECALL NUMBER To be determined CODE Product codes and lot numbers: 1) M0068201750, M0068201761 13012588 13013354 13020011 13020012 13021316 13022523 13022524 13022543 13022968 13023331 13030483 13030796 13030799 13030917 13030918 13032173 13032178 13032179 13033150 13033375 13033376 13033377 13040440

13042352 13042812 13042880 13042926 13042927 13042928 13044122 13044123 13050084 13050087 13050094 13050341 13050343 13050344 13051741 13051742 13052980 13053381 13053382 13053383 13060123 13060124 13060126

13060129 13061014 13061176 13064147 13070073 13070074 13070075 13070995 13070996 13070997 13072664 13072676 13074559 13080239 13080326 13080328 13080329 13080336 13080776 13080777 13080778 13081646 13081647

13083095 13083096 13083904 13083906 13090197 13090198 13091340 13092837 13092838 13100204 13102622 13102623 13102624 13103869 13103870 13103871 13110084 13110087 13110095 13112300 13112927 13112928 13120574

13120575 13120579 13120580 13121190 13121540 14010058 14010973 14010975 14010976 14011278 14011279 14012203 14012204 14012205 14012206 14012413 14013245 14013264 14013267 14014115 14020041 14020044 14020172

14020173 14020175 14020756 14020763 14023503 14030212 14030213 14030214 14032223 14032224 14040101 14040114 14040739 14040740 14041065 14041066 14041513 14043216 14043217 14044493 14050180 14050691 14050692

14050948 14051564 14051565 14052162 14053336 14053841 14060223 14060232 14060481 14060482 14061576 14061577 14070008 14070107 14070114 14071692 14073164 14080342 14080345 14080346 14080348 14090059 14090060

14090221 14091501 14091514 14091517 14091739 14094708 14100671 14100672 14100804 14100813 14103081 14103085 14103169 14111772 14111910 14112932 14112936 14120575

2) TLC200, TLC5042, TLC5042-I 13010660 13010821 13012161 13023921 13023922 13023923 13031223

15

13033222 13033223 13033746 13040364 13040442 13040443 13040444 13040653 13041737 13042353 13042354 13042535 13042592 13042817 13043571 13043572 13044498 13050115 13050342 13050345 13050444

13050445 13050721 13050949 13050950 13051744 13053251 13060132 13060533 13060623 13060717 13060718 13062877 13062878 13062950 13070064 13071442 13071443 13072977 13073268 13073907 13080321

13080324 13080455 13080476 13080507 13080508 13080509 13080533 13080534 13081293 13081294 13081545 13082444 13082445 13082446 13083129 13083145 13090029 13090030 13090124 13090303 13090304

13092465 13093753 13093754 13100150 13100768 13100769 13101225 13102112 13102262 13103897 13110029 13111529 13120562 13120989 14010071 14020121 14020136 14020137 14020591 14022601 14022730

14023588 14030299 14030316 14031112 14031837 14031951 14031977 14032005 14032006 14032670 14040252 14043702 14044133 14050084 14051689 14053107 14053108 14053338 14053364 14054217 14060348

14060350 14061703 14062541 14064105 14064187 14070239 14072681 14072682 14074806 14080350 14080353 14081538 14091381 14092205 14092206 14092857 14093927 14094707 14100083 14100084 14100455

14100456 14103170 14104555 14110172 14110283 14110285 14113449 14120607 14120669 14121767 14121769 15011648 15011654 15011655 15011659 15013564 15020188 15021925 15023292

3) TLC300 13012100 13012589 13020221 13021643 13030567 13031502 13032101 13042531 13043413 13043573

13050346 13050962 13051743 13060531 13062360 13062876 13062951 13070300 13072976 13081450

13090299 13091108 13092185 13092186 13100436 13100448 13103900 13104409 13111530 13120990

13121864 13121865 13123456 13123457 14011196 14011200 14013957 14020123 14020917 14021900

14022810 14023322 14030317 14040251 14044097 14053109 14053112 14053114 14053115 14053337

14054326 14062474 14064104 14091274 14091365 14092049 14092856 14100564 14100566 14102170

14102171 14105109 14105110 14112492 14123036 15014566 15020186 15020189 15021929

4) TLC5042-M 13010660 13010821 13023921 13023922 13033152

13033153 13033222 13042811 13042813 13043571

13043572 13050949 13050950 13051744 13060130

13062877 13070061 13070066 13070077 13071443

13072666 13074116 13080508 13080509 13080533

13081293 13081294 13090200 13090202 13100006

13100020

MANUFACTURED & RECALLED BY Applied Medical Technology, Inc, Brecksville, OH QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Some devices subject to this recall may contain open sterile pouch seals. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Quadrox-i Oxygenators, Rotaflow Centrifugal Pumps, HLS Set Advanced and Custom

Tubing Sets RECALL NUMBER Safety notice CODE BE-HMODxxxxx, BEQ-HMOxxxxx, BEQ-HMODxxxxx, BO-VKMOxxxxx, HMOxxxxx,

HMODxxxxx, VKMOxxxxx, XHMOxxxxxU, XHMOD30000U, XVKMOxxxxxU, X1895, XVIVOHMO70100U, BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32-USA, RF-32, RF-32-USA, RF-32u, BEQ-HLS5050, 70105.2797, BEQ-HLS7050, 70105.2794, BO-HLS7050, 70105.2786, Txxxxx, TOPxxxxx, BE-TOPxxxxx, BO-TOPxxxxx, BO-Txxxxx, BEQ-Txxxxx, BEQ-TOPxxxxx

16

MANUFACTURED & RECALLED BY Maquet Medical Systems, Wayne, NJ QUANTITY Not available at publication DISTRIBUTION Nationwide REASON The potential risk of exposure to endotoxin with use of these products delivered prior to

January 1, 2016. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Birmingham Hip Resurfacing (BHR) System RECALL NUMBER To be determined CODE Catalog numbers: 74121138, 74123140, 74121142, 74123144, 74121146, 74120144,

74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152,74120152, 74120154, 74120246,74122248, 74120250, 74122252, 74120254

MANUFACTURED & RECALLED BY Smith & Nephew Inc, Memphis, TN QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Due to observed revision rates which are higher than established benchmarks. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT DEFENDO suction valves RECALL NUMBER To be determined CODE PN 100305, 100310; lot numbers 789658, 791293, 791343 MANUFACTURED & RECALLED BY Medivators Inc, Minneapolis, MN QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Some suction valves may contain a component with dimensional discrepancy which may

cause sticking during an endoscopy procedure. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT GEMflex Coil, 3.0T, used with GE Healthcare 3.0T Scanners RECALL NUMBER Field correction CODE 16-L Array 5430008-2, 16-M Array 5430008-3, 16-S Array 5430008-4, Flex Interface

5430008-5 MANUFACTURED BY NeoCoil, Pewaukee, WI RECALLED BY GE Healthcare, Wauwatosa, WI QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Part of the cable assembly may overheat when the device is used. You may continue use the

device with the following precautions: place the foam cover over the Interface, do not allow the cable to touch the patient (use a pad), keep the length of the cable in the bore to a minimum, the system is indicated for adult use only.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT CARDIOSAVE Hybrid Intra-Aortic Ballon Pump (IABP) RECALL NUMBER Field correction CODE Model number 0998-00-0800-53 MANUFACTURED & RECALLED BY Maquet, Wayne, NJ QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Maquet has received thirteen power supply complaints that were determined to be related to

suboptimal thermal management. Maquet anticipates having a replacement power supply available by June 2015.

17

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Quick Connect RECALL NUMBER Field correction CODE Model number QKC1736E, QKC1737E MANUFACTURED & RECALLED BY STERIS Corp, Erie, PA QUANTITY Not available at publication DISTRIBUTION Nationwide REASON One of the hysteroscope models (Karl Storz 11264BBU1) listed for processing in

QKC1736E and QKC1737E has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions. A user will observe an unused Quick Connect port adapter.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Naturalyte Liquid Acid Concentrate RECALL NUMBER Z-0887-2016 CODE Catalog Number: 08-2301-3, Lot Number: 15STAC072, Exp Date: 2017-12-31MANUFACTURED & RECALLED BY Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA QUANTITY 848 (212 cases) DISTRIBUTION KS, LA, MS, OK, TX REASON On the label calcium (Ca) listed in the right upper corner of the label (red background)

incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only,

Sterile RECALL NUMBER Z-0886-2016 CODE REF 543965; 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565,

73J1500566, 73K1500193 MANUFACTURED & RECALLED BY Teleflex Medical, Research Triangle Park, NC QUANTITY 543 ea DISTRIBUTION CA, MI, NC, PA, TX, VA REASON The clip in the applier may be missing a boss. A boss is the part of the clip that is used to

hold the clip within the applier jaws prior to application. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Helioseal Clear Refill 1 x 1.25g RECALL NUMBER Z-1026-2016 CODE REF/Product Code/Art No 558521AN, Lot U29336; REF/Product Code/Art No 558520AN,

Lots U33966, U35661, U50469 MANUFACTURED & RECALLED BY Ivoclar Vivadent, Inc, Buffalo, NY QUANTITY 406 units DISTRIBUTION NY, PA, FL, IN, IA, TX, CA REASON Complaints were received claiming the material failed to polymerize under the curing light.

After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.

-----------------------------------------------------------------------------------------------------------------------------------------------

18

PRODUCT Multicompartmental Knee (MCK) System RECALL NUMBER Z-1031-2016 CODE Catalog number 180601, 180602, 180603, 180604, 180605, 180606, 180607, 180608,

180611, 180612, 180613, 180614, 180615, 180616, 180617, 180618; lot number 26110111, 26300512-01, 26110112-01, 26090311-01, LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, 26220512-02, LET 1388860512, 26010511-01, 26310811-01, 26050112-01, 26090512-01, 26280412-01, 26310512-01, 26270512-01, 26250511-01, LET1464570912, 26300412-01, 26140412-01, 26050212-01, 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, 26230411-01, 26141111-01, 26131111-01, 26050211-01, 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, 26060211-01, 26271011-01, 26240711-01, 36031211-1, 26180512-01, 26440611-01, 26190612-01, 2610012-01, 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, 26310612-01, 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, LOT1388810512, 26360512-01, 26060311-01, 26061211-01

MANUFACTURED & RECALLED BY Mako Surgical Corp, Plantation, FL QUANTITY 146 DISTRIBUTION AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH,

OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WY REASON Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell

packaging configuration exhibited damage, compromising the sterile barrier. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Kopans Breast Lesion Localization Needle RECALL NUMBER Z-1028-2016 CODE Catalog number DKBL-20-7.0-A, lot number 6215428 MANUFACTURED & RECALLED BY Cook Inc, Bloomington, IN QUANTITY 134 DISTRIBUTION AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, PA REASON Product potentially exposed to body fluids during processing. Potential adverse events that

may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Precision MPi x-ray system RECALL NUMBER Z-0753-2016 CODE NRT number 02980000 MANUFACTURED & RECALLED BY Regulatory Insight, Inc, Littleton, CO QUANTITY 43 DISTRIBUTION TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS, OH REASON It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi x-ray system

may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Karma Flexx Wheelchair RECALL NUMBER Z-1025-2016 CODE Item #: 935-0245H6 Flexx (KM852216), Serial #: TM14-A03982-TM14-A03991; Item #:

935-0246H6 Flexx (KM852218), Serial #: TM14-A03992-TM14-A04012; Item #: 935-0247H6 Flexx (KM852220), Serial #: TM14-A4013-TM14-A04017

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MANUFACTURED & RECALLED BY Karman Healthcare Inc, City of Industry, CA QUANTITY 35 DISTRIBUTION CA, NY, TX, WA REASON Incorrect size screws and corresponding hardware were installed on the front caster fork

brackets. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT HipLOC CHS Plate/Lag Screw Introducer RECALL NUMBER Z-0885-2016 CODE Catalog Number: 35-000263; Lot Number: 1807188, 1807189, 1943563, 2577847 MANUFACTURED & RECALLED BY Biomet, Inc, Warsaw, IN QUANTITY 23 units DISTRIBUTION AZ, GA, IL, KY, MI, MN, MO, NC, NJ, PA, UT REASON A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and

would not accept the introducer coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Flexor Check-Flo Introducer, catheter introducer RECALL NUMBER Z-0865-2016 CODE Catalog number KCFW-6.0-35-70-RB-HFANL0-HC, lot number 6166304 MANUFACTURED & RECALLED BY Cook Inc, Bloomington, IN QUANTITY 25 DISTRIBUTION CA, FL, OK, OH, MI, TX, NJ, NY REASON Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr

devices. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer RECALL NUMBER Z-1030-2016 CODE Catalog #K7024, SMN 10445889, Lot #15246MA MANUFACTURED & RECALLED BY Siemens Healthcare Diagnostics, Inc, Newark, DE QUANTITY 1637 units DISTRIBUTION CA REASON Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay

errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patient’s clinical status, etc.

----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT EndoVive 3s Low Profile Balloon Kits RECALL NUMBER Z-0912-2016 to Z-1016-2016 CODE Part number M00548460, M00548330, M00548220, M00548340, M00548500,

M00548660, M00548820, M00549310, M00548230, M00548350, M00548510, M00548670, M00548830, M00549320, M00548240, M00548360, M00548520, M00548680, M00548840, M00549330, M00549470, M00548250, M00548370, M00548530, M00548690, M00548850, M00549340, M00549480, M00548260, M00548380, M00548540, M00548540, M00548700, M00548860, M005489350, M005489490, M00548270, M00548390, M00548550, M00548870, M00549360, M00549500, M00548280, M00548400, M00548560, M00548720, M00548880,

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M00549370, M00549510, M00548290, MM00548410, M00548570, M00548890, M00549380, M00549520, M00548300, M00548420, M00548580, M00548740, M00548900, M00549390, M00549390, M00548310, M00548430, M00548590, M00548750, M00548910, M00549400, M00549540, M00548320, M00548440, M00548600, M00548760, M00548920, M00549410, M00549550, M00548450, M00548610, M00548770, M00548930, M00549420, M00549560, M00548460, M00548620, M00548780, M00549430, M00549570, M00548470, M00548630, M00548790, M00548950, M00549440, M00549580, M00548480, M00548640, M00548800, M00548960, M00549450, M00549590, M00548490, M00548650, M00548810, M00548970, M00549460, M00549600; Lot number 929614, 928905, 930835, 911102, 915402, 915902, 919001, 920602, 928902, 930823, 911105, 915905, 920605, 928906, 930863, 928913, 923307, 929719, 929724, 930138, 911103, 915403, 915903, 919002, 920603, 928903, 930822, 911106, 915906, 919003, 920606, 928907, 930837, 928914, 928918, 929708, 929725, 930139, 911104, 915404, 915904, 920604, 928904, 930821, 911107, 915907, 919004, 920607, 928908, 930838, 911110, 915910, 920210, 920610, 928915, 930825, 928919, 929709, 929726, 930140, 930153, 929601, 911108, 915408, 915908, 920608, 928909, 930839, 911111, 915911, 920211, 919005, 920611, 928916, 930826, 928920, 929710, 929727, 930141, 930154, 929602, 911109, 915409, 915909, 920609, 928910, 930840, 911112, 915912, 919006, 920612, 929624, 911112, 915912, 919006, 920612, 929624, 928921, 929711, 929728, 930142, 930155, 929603, 928911, 928917, 929625, 929729, 930143, 930156, 929604, 928912, 929626, 928923, 929713, 930129, 930144, 930827, 929605, 929609, 929622, 923308, 930145, 930828, 929606, 929610, 929623, 929715, 930130, 930146, 930841, 929607, 929611, 929701, 929716, 930131, 930147, 930829, 929608, 929612, 929702, 929717, 929132, 930148, 930834, 929613, 929703, 929718, 930133, 923309, 930830, 929614, 929704, 929720, 930149, 930831, 929615, 929705, 929721, 930135, 930150, 930832, 929616, 929706, 929722, 930136, 930151, 930833, 929617, 929707, 929723, 930137, 930152, 923310

MANUFACTURED & RECALLED BY Xeridiem Mediem Medical Devices Inc, Tucson, AZ QUANTITY Not available at publication DISTRIBUTION MA REASON A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or

close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

-------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT 1) Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only RECALL NUMBER D-0719-2016 PRODUCT 2) Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only RECALL NUMBER D-0720-2016 PRODUCT 3) Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only RECALL NUMBER D-0721-2016 CODE 1) NDC 55111-663-30 – lot number C404795, C404796, C404797, C406272, C406273,

C406274, C406518, C409586, C409587, C409588, C501835, C501836, C501837, C503797, C503798, C505009, C505568, C505569; 2) NDC 55111-664-30 – lot number C404653, C404654, C404655, C505010; 3) NDC 55111-665-30 – C404440, C404946, C505704

MANUFACTURED & RECALLED BY Dr Reddy's Laboratories, Inc, Princeton, NJ QUANTITY 1) 9155 bottles, 2) 4383 bottles, 3) 11123 bottles DISTRIBUTION Nationwide REASON This is an update to a notice posted on 11/6/15 to include additional NDC and lot numbers.

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

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PRODUCT Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl

Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only RECALL NUMBER D-0665-2016 CODE NDC 53598-0012-15, lot number 20150326 MANUFACTURED & RECALLED BY Bonita Pharmaceuticals, LLC, Westland, MI QUANTITY 3,308 boxes DISTRIBUTION Nationwide REASON Marketed without an approved NDA/ANDA. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Rx Only,

Packaged in E-Tanks, M6-Tanks, and D-Tanks RECALL NUMBER To be determined CODE NDC 10006-001; lot number 1102151, 1102152, 1102153, 1102154, 1103151, 1103152

1103153, 1103154, 1109151, 1109152, 1109153, 1109154, 1109155, 1109156, 1112151, 1112152, 1116151, 1116152, 1116153, 1116154, 1116155, 1115166, 1125151, 1125152, 1202151, 1202152, 1202153, 1203151, 1203152, 1203153, 1204151, 1204152, 1204153, 1208151, 1208152, 1208153, 1208154, 1208155, 1208156, 1222151, 1222152, 1208153, 1230151, 1230152, 107161, 107162, 107163, 112161, 112162, 112163, 112164, 119161, 119162, 119163, 120161, 120162, 120163, 120164, 120165, 120166, 202161, 202162, 202163, 202164, 202165

MANUFACTURED & RECALLED BY Medical Park Homecare, Inc, Bartlesville, OK QUANTITY Not available at publication DISTRIBUTION Nationwide REASON CGMP Deviations: high pressure gauges, vacuum gauges, and thermometers used have out

of date calibration. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Minocycline Hydrochloride, 100 mg Capsules, 30 ct RECALL NUMBER To be determined CODE NDC 50268-569-13, lot number 13650 MANUFACTURED & RECALLED BY AvKARE, Inc, Pulaski, TN QUANTITY Not available at publication DISTRIBUTION Nationwide REASON A lot number discrepancy between the saleable unit (carton) and the individual blisters

within. The carton states lot 13650 while the individual blister states lot 13560. ----------------------------------------------------------------------------------------------------------------------------------------------- PRODUCT Sulfameth+Trimeth Tab 8C/160 MUT 100@ RECALL NUMBER To be determined CODE NDC 53489014601, lot number 6727001 MANUFACTURED & RECALLED BY Sun Pharmaceutical Industries Ltd, Mumbai, India QUANTITY Not available at publication DISTRIBUTION Nationwide REASON Due to foreign material found in one tablet. -----------------------------------------------------------------------------------------------------------------------------------------------