RENASYS Sterile Transparent Film and all the RENASYS recall: Sterility Concern

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 2016040687 - US ONLY Product Code 66020934 RENASYS G Medium with Soft Port - Lots #'s 2015100135, 2015100315, 2015100316, 2015110540, 2016040715, and 2016040963  US ONLY Product Code 66020935 RENASYS G Large with Soft Port- Lots #'s 2015100282, 2015100317, 2015110542, and 2016041021  US ONLY Product Code 66020936 RENASYS G X Large with Soft Port Lot # 2016041035  US ONLY Product Code 66800394 RENASYS Transparent Film Lots #'s 2014010176, 2014011449, 2014030463, 2014040241, 2014050736, 2014051132, 2014061169, 2014113986, 2015020655, 2015040522, 2015050927, 015060209, 2015071095, 2015101044, 2015110749, 2015120664, and 2015121019 - GLOBAL Product Code 66800494 RENASYS G Medium Kit Flat Drain Lots #'s 02014P, 05014D, 06914E, 13414K, 15414T, 16014CV, 18114AV, 23214D, 25214J, and 26515H  GLOBAL (NOT US) Product Code 66800495 RENASYS G Large Kit 19Fr Round Drain Lots #'s 00815K, 14014L, 23314E, 25214H, and 32214D  GLOBAL (NOT US) Product Code 66800496 RENASYS G Large Kit Flat Drain Lots #'s 00815N, 01215G, 02214J, 05014F, 09014K, 09914K, 16014F, 17514T, 24114D, 25214K, 28015M, and 31714H  GLOBAL (NOT US) Product Code 66800497 REANSYS G X-Large Kit 19Fr Round Drain Lot # 05014M  GLOBAL (NOT US) Product Code 66800932 RENASYS High Output Fistula Kit Lots #'s 07715M, 09214H, 15514G, 18814K, and 27915G  GLOBAL (NOT US) Product Code 66800933 RENASYS G Small with Soft Port Lots #'s 2014010183, 2014011414, 2014020037, 2014021119, 2014021324, 2014021837, 2014030094, 2014030840, 2014030933, 2014031770, 2014040674, 2014041232, 2014041489, 2014050297, 2014050582, 2014051447, 2014051561, 2014060367, 2014060603, 2014060606, 2014071097, 2014080670, 2014080729, 2014091593, 2014091612, 2014091896, 2014091951, 2014102569, 2014103236, 2014103501, 2014103566, 2014125085, 2014125464, 2015016495, 2015016793, 2015016824, 2015020606, 2015020633, 2015021230, 015030904, 2015030938, 2015031168, 2015050397, 2015050706, 2015051210, 2015051333, 2015060715, 2015060718, 2015060878, 2015070001, 2015070021, 2015070057, 2015070243, 2015091343, 2015100464, 2015100652, 2015100707, 2015100859, 2015100968, 2015101007, 2015120041, 2015120046, 2015120052, 2015120061, 2015120411, 2016010750, 39907, 40151, 43250, 3251, and 43252  GLOBAL (NOT US) Product Code 66800934 RENASYS G Medium with Soft Port Lots #'s 2014010306, 2014010307, 2014010965, 2014011574, 2014020362, 2014020972, 2014021207, 2014021208, 2014021930, 2014021931, 2014022059, 2014022086, 2014030302, 2014030816, 2014030934, 2014031153, 2014031404, 2014031758, 2014040175, 2014041509, 2014041510, 2014042119, 2014050158, 2014050207, 2014050345, 2014050586, 201405062, 2014051041, 2014051041, 2014060684, 2014060833, 2014061007, 2014061442, 2014061669, 2014070114, 2014070520, 2014070979, 2014071068, 2014080794, 2014080836, 2014080909, 2014090181, 2014090267, 2014091758, 2014091835, 2014092091, 2014102295, 2014102318, 2014114098, 2014114125, 2014114183, 2014114284, 2014124756, 2014124797, 2014125114, 2014125177, 2014125233, 2015020672, 2015020750, 2015020781, 2015020841, 2015021100, 2015021102, 2015031154, 2015040916, 2015050291, 2015050995, 015050996, 2015051048, 2015051382, 2015051409, 2015060395, 2015060402, 2015060912, 2015060921, 2015060979, 2015061078, 2015070313, 2015070335, 2015070348, 2015091344, 2015100024, 2015100672, 2015101328, 2015101360, 2015101522, 2015110440, 2015110767, 2015110809, 2015110931, 2015110988, 2015110989, 2015111015, 2015111261, 2015121208, 2015121237, 2016010018, 2016010772, 2016010790, 39908, 40152, 43249, 43432, 43433, 43434, 43435, and 43558  GLOBAL (NOT US) Product Code 66800935 RENASYS G Large with Soft Port Lots #s 2014010875, 2014010876, 2014010919, 2014010940, 2014011209, 2014011229, 2014011418, 2014020026, 2014020946, 2014021122, 2014021838, 2014021839, 2014022085, 2014030813, 2014030841, 2014031293, 2014031354, 2014031399, 2014040860, 2014041269, 2014041410, 2014042109, 2014042113, 2014050898, 2014051040, 2014051655, 2014060089, 2014060169, 2014060274, 2014061051, 2014061333, 2014061438, 2014080369, 2014080549, 2014090036, 014091306, 2014102445, 2014102629, 2014102650, 2014114359, 2014114527, 2014114577, 2014124708, 2014125271, 2014125307, 2014125307, 2015020993, 2015021023, 2015040809, 2015051050, 2015051077, 2015060486, 2015060493, 2015060494, 2015060507, 015061065, 2015061135, 2015061224, 2015061265, 2015070371, 2015100539, 2015100585, 2015100603, 2015100611, 2015110023, 2015110257, 2015110291, 2015110435, 2015120445, 2015120457, 2015120752, 2015120762, 2016010895, 2016011075, 39909, 40153, 43535, 43559, 43565, and 43714  GLOBAL (NOT US) Product Code 66800936 RENASYS G X Large with Soft Port Lots #'s 2014010874, 2014010961, 2014040956, 2014050897, 2014080970, 2014103611, 2015021068, 2015021444, 2015040678, 2015070796, 2015100001, 2015100272, 2015101377, and 2015120027 -  GLOBAL (NOT US) Product Code 66801255 RENASYS G 10Fr Round Drain Kit Lots #'s 01415G, 02015E, 04916J, 16914G, 2014050828, 1015G, 21015H, and 32214L -  GLOBAL (NOT US) Product Code 66801256 RENASYS G 10mm Flat Drain Kit Lots #'s 05516D, 05715H, 08915E, 11214JV, 11414AV, 11414BV, 16914H, 2013050783, 2013060968, 20915T, 32115L, and 32314M  GLOBAL (NOT US) Product Code 66801257 RENASYS 15Fr Channel Drain Kit Lots #'s 08915D, 16914J, 19615V, 2014030237, 2014060209, 20815K, 20915G, 23014L, 28815K,32215G, and 32814J  GLOBAL (NOT US) Product Code 66801258 RENASYS G 19Fr Round Drain Kit Lots #'s 05316P, 17014K, 2014030238, 20915K, and 32314T  GLOBAL (NOT US)

Product

RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who…

Recalling firm

Smith & Nephew, Inc.

Quantity

45,455 devices (in the USA)

Distribution

Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.

Recall date

September 28, 2016

Classification

Class II

Status

Ongoing

Agency

FDA (device)