{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "148677", "product_res_number": "Z-2848-2016", "event_date_initiated": "2016-07-21", "event_date_created": "2016-09-20", "recall_status": "Open, Classified", "res_event_number": "74885", "product_code": "OMP", "k_numbers": [ "K061919", "K142979" ], "product_description": "RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film\nIs 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.", "code_info": "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)", "firm_fei_number": "3006760724", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "970 Lake Carillon Dr Ste 110 970 Lake Carillon Dr", "address_2": "Ste 110", "city": "Saint Petersburg", "state": "FL", "postal_code": "33716-1130", "additional_info_contact": "Keith Matthews\n727-642-5849", "reason_for_recall": "Sterility seal integrity failures on the Renasys Sterile Transparent Film", "root_cause_description": "Unknown/Undetermined by firm", "action": "Smith & Nephew sent an Urgent Medical Device Removal Notice dated July 21, 2016, to all consignees informing them of a voluntary medical device recall involving Sterile RENASYS Transparent Film and the RENASYS Dressing Kits that contain the folded RENASYS Transparent Film. Smith & Nephew have identified that the process of folding the Sterile RENASYS\" Transparent Film pouch during its packaging has the potential to damage the pouch seals resulting in a loss of sterility of the product. The loss of sterility has the potential to contribute to a local infection.\n \nActions to be taken by customers and distributors:\nAll affected Sterile RENASYS Transparent Film and the RENASYS Dressing Kits that contain the folded RENASYS Transparent Film must be returned to Smith & Nephew.\nFor questions regarding this recall call 727-642-5849.\nUsers must complete the Acknowledgment, Receipt and Confirmation of Return Form attached with this notice and return to fieldactions@smith-nephew.com. This will trigger the return authorization process if you have product to return. An Acknowledgement, Receipt and Confirmation of Return Form must be returned even if you do not have any affected product in your inventory. Device users are reminded that reports of adverse events experienced with medical devices should be reported to FDAs MedWatch Adverse Event Reporting program. Reports may be made online, by fax or by mail. For questions, or additional information please contact Customer.Large@smith-nephew.com.", "product_quantity": "45,455 devices (in the USA)", "distribution_pattern": "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\nArgentina, 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.", "openfda": { "k_number": [ "K141017", "K203369", "K052456", "K113291", "K182191", "K212320", "K083357", "K150006", "K160451", "K080897", "K132446", "K241134", "K243187", "K143004", "K061367", "K221585", "K151240", "K163387", "K100657", "K141961", "K092992", "K203316", "K183543", "K211277", "K231646", "K161418", "K132225", "K254019", "K071301", "K210107", "K121883", "K214112", 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"K093564", "K142956", "K142646", "K182458", "K062227", "K102956", "K132936", "K141033", "K161128", "K120499", "K161948", "K233614", "K181929", "K143726", "K190119", "K191760", "K082676", "K143016", "K133232", "K041642", "K222859", "K070904", "K153209", "K082426", "K241515", "K132741", "K143362", "K061435", "K232379", "K161432", "K162129", "K100821", "K160487", "K201571", "K100823", "K091585", "K162610", "K223388", "K111333", "K172005", "K151261", "K111949", "K113199", "K133276", "K200390", "K120033", "K223041", "K202157", "K133333", "K253429", "K173426", "K151263", "K172725", "K161570", "K112853", "K090258", "K161410", "K152741", "K202898", "K180618", "K191460", "K992448", "K143301", "K251646", "K090130", "K080275", "K180614", "K161797", "K253199", "K151326", "K220560", "K140634", "K141437", "K141847", "K082211", "K102001", "K132004", "K113236", "K971548", "K082415", "K162790", "K180415", "K062456", "K080357", "K182323", "K221888", "K091470", "K021501", "K083375", "K103156", "K181822" 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] }