{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104437", "product_res_number": "Z-0178-2012", "event_date_initiated": "2011-07-13", "event_date_posted": "2011-11-09", "recall_status": "Terminated", "event_date_terminated": "2013-03-04", "res_event_number": "60104", "product_code": "FTM", "k_numbers": [ "K070560" ], "product_description": "LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement\nCatalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm).\n\nIntended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.", "code_info": "The following lots begin with the letter 'S' 10664; 10665; 10666; 10667; 10668; 10670; 10671; 10672; 10678; 10679; 10680; 10683; 10684; 10685; 10686; 10688; 10689; 10690; 10691; 10698; 10700; 10701; 10702; 10777; 10778; 10780; 10838; 10844; 10845; 10847; 10848; 10851; 10863; 10864; 10866; 10867; 10871; 10872; 10875; 10877; 10896; and 10910.", "firm_fei_number": "1000306051", "recalling_firm": "LifeCell Corporation", "address_1": "1 Millennium Way", "city": "Branchburg", "state": "NJ", "postal_code": "08876-3876", "additional_info_contact": "Ms. Bonnie Samuel\n908-947-1042", "reason_for_recall": "The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.", "root_cause_description": "PMA", "action": "LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.", "product_quantity": "2651 sublots (of 42 lots)", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K170763", "K820619", "K081272", "K192616", "K992537", "K041923", "K142887", "K961810", "K043388", "K063178", "K140501", "K971048", "K160181", "K062729", "K091499", "K063556", "K060989", "K213163", "K050246", "K233991", "K031969", "K162752", "K061892", "K090880", "K112423", "K113460", "K162934", "K153633", "K831723", "K023237", "K162570", "K082682", "K040119", "K083039", "K053655", "K051879", "K123356", "K940205", "K111584", "K091142", "K162965", "K020049", "K161221", "K991567", "K011025", "K152206", "K831727", "K150668", "K223052", "K041669", "K852011", "K001738", "K112786", "K160869", "K021160", "K050337", "K040835", "K183472", "K961811", "K101587", "K083898", "K052322", "K033985", "K060829", "K141084", "K844225", "K034039", "K070405", "K141721", "K061030", "K162554", "K973379", "K031332", "K030782", "K214070", "K896946", "K120019", "K073219", "K060984", "K043259", "K923657", "K040621", "K071986", "K080452", "K182255", "K021105", "K070560", "K082176", "K094061", "K203600", "K162388", "K040868", "K851086", "K183398", "K103787", "K172937", "K083823", "K011027", "K142326", "K021107", "K150712", "K844228", "K241126", "K013625", "K983162", "K041140", "K071807", "K213125", "K192452", "K831725", "K134033", "K982330", "K201313", "K040364", "K162461", "K073391", "K081882", "K110402", "K062558", "K120605", "K130547", "K140306", "K040756", "K062320", "K141053", "K243595", "K182493", "K182259", "K070738", "K250598", "K111436", "K133306", "K051048", "K071016", "K053562", "K171817", "K090778", "K021056", "K830889", "K262406", "K915774", "K081538", "K963175", "K170016", "K200311", "K132025", "K042809", "K110581", "K082687", "K071065", "K192615", "K062696", "K922308", "K020455", "K062915", "K980431", "K142070", "K831726", "K173242", "K122048", "K201000", "K894580", "K991296", "K203496" ], "device_name": "Mesh, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2", "registration_number": [ "9615742", "3015413883", "3045042524", "1416980", "3003418325", "3012669262", "3015543569", "3003604053", "2124215", "1047843", "2132242", "1647098", "3013307971", "3012448339", "3009417901", "3000931034", "3010178296", "8043792", "3010894343", "9617465", "3005636544", "3009882464", "3015531529", "1111225", "3010155661", "3018094310", "1220948", "2023811", "3014003617", "3013820501", "9680579", "3010600625", "3012358417", "2530154", "1048735", "1319660", "3016003911", "2183620", "3016823837", "3014461810", "3008868758", "2024024", "1220477", "1018470", "1450662", "3008812560", "3016429246", "3004170064", "3027383505", "1213643", "1526534", "3000215346", "2249852", "1835959", "1221816", "3005920706", "3004464325", "3012547639", "3002807561", "3004681519", "3002924436", "3027448274", "3013666218", "1000393132", "1649390", "8010177", "1820334", "3009039068", "2245304", "2030598", "1818910", "1018233", "1121308", "3002719998", "3012102437", "3010400367", "1550222", "2246552", "3005497913", "3036710971", "2244478", "2183744", "3003300673", "9614442", "3007321028", "3009504230", "3003936139", "3010513348", "3006017180", "3005619880", "3009493875" ], "fei_number": [ "3015413883", "3045042524", "1416980", "3003418325", "1000203464", "3012669262", "3015543569", "3003604053", "2124215", "1047843", "3013307971", "3012448339", "3009417901", "3000931034", "3010894343", "3005636544", "3009882464", "3015531529", "3002821504", "1111225", "1000307073", "3003769549", "3010155661", "3018094310", "1220948", "1000143837", "2023811", "3003110073", "3014003617", "3013820501", "3010600625", "3012358417", "1000136269", "1048735", "3016003911", "2183620", "3016823837", "3014461810", "3008868758", "2024024", "1220477", "1018470", "1000518731", "1450662", "3008812560", "3016429246", "1000136478", "3004170064", "3027383505", "3002808269", "1213643", "1526534", "3000215346", "1000306051", "3005920706", "3004464325", "3012547639", "3002807561", "3003870583", "3002924436", "3027448274", "3013666218", "1000393132", "3003521774", "3000303710", "1820334", "3009039068", "2245304", "1818910", "1018233", "1121308", "3002719998", "3012102437", "3010400367", "3008817245", "1000148471", "3000718467", "1550222", "2246552", "3005497913", "3036710971", "2183744", "3003300673", "3007321028", "3009504230", "3003936139", "3010513348", "3006017180", "3002340648", "3005619880", "3009493875" ] } } ] }