Reported Sep 28, 2016 · Ongoing
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film…
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 970 Lake Carillon Dr Ste 110 · Saint Petersburg, FL · 33716-1130
Is this the product you have?
- RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
- Lot codes and dates
- 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)
- Amount recalled
- 45,455 devices (in the USA)
Where it was sold
Why it was recalled
Sterility seal integrity failures on the Renasys Sterile Transparent Film
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Smith & Nephew, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.