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.

Recall details

Manufacturer

Smith & Nephew, Inc.

Distributor

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.

Lot

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, 2014

Risk classification

Class II

Area (FDA)

device

Country

United States