{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94590", "product_res_number": "Z-0162-2011", "event_date_initiated": "2010-09-13", "event_date_posted": "2010-10-28", "recall_status": "Terminated", "event_date_terminated": "2012-08-17", "res_event_number": "56826", "product_code": "KGZ", "product_description": "IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.", "code_info": "B27815A, Item no 663002, Graft Jacket Xpress 2011-01, Optiva IV Catheter Expiration 2010-05 B28417A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28419A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B28420A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B29170A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29172A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29174A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 B29381A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B29923A, Item no 663002, Graft Jacket Xpress 2011-03, Optiva IV Catheter Expiration 2010-05 B29927A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30035A, Item no 663002, Graft Jacket Xpress 2011-06, Optiva IV Catheter Expiration 2010-05 B30036A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30039A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B3004A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30043A, Item no 663002, Graft Jacket Xpress 2011-02, Optiva IV Catheter Expiration 2010-05 B30701A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30702A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30703A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B30708A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31035A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B31036A, Item no 663002, Graft Jacket Xpress 2011-05, Optiva IV Catheter Expiration 2010-05 B31038A, Item no 663002, Graft Jacket Xpress 2011-04, Optiva IV Catheter Expiration 2010-05 B32670A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B32674A, Item no 663002, Graft Jacket Xpress 2011-08, Optiva IV Catheter Expiration 2010-05 B34512A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B34514A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-06 B34516A, Item no 663002, Graft Jacket Xpress 2011-12, Optiva IV Catheter Expiration 2010-05 B35329A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35334A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35336A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35623A, Item no 663002, Graft Jacket Xpress 2012-02, Optiva IV Catheter Expiration 2011-06 B35624A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35625A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B35627A, Item no 663002, Graft Jacket Xpress 2012-03, Optiva IV Catheter Expiration 2011-06 B37232A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B38274A, Item no 663002, Graft Jacket Xpress 2012-06, Optiva IV Catheter Expiration 2011-06 B5835A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 B6092A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05 C26276A, Item no 663002, Graft Jacket Xpress 2011-09, Optiva IV Catheter Expiration 2010-05 C6056A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6072A, Item no 663002, Graft Jacket Xpress 2010-10, Optiva IV Catheter Expiration 2010-05 C6085A, Item no 663002, Graft Jacket Xpress 2010-12, Optiva IV Catheter Expiration 2010-05", "firm_fei_number": "1000306051", "recalling_firm": "LifeCell Corporation", "address_1": "1 Millennium Way", "city": "Somerville", "state": "NJ", "postal_code": "08876-3876", "additional_info_contact": "Carrie Falcone\n908-947-1042", "reason_for_recall": "Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.", "root_cause_description": "Labeling mix-ups", "action": "Lifecell Corporation, Branchburg, NJ initiated a recall to their distributor Wright Medical Technology, Arlington, TN on 9/13/2010.", "product_quantity": "1507 kits", "distribution_pattern": "Nationwide Distribution: USA, to distributor in TN", "openfda": { "k_number": [ "K790597", "K821525", "K022306", "K780259", "K973183", "K974295", "K895041", "K802286", "K942315", "K810531", "K760383", "K760385", "K810530", "K802367", "K781846", "K791803", "K821245", "K855078", "K896087", "K760384", "K873009", "K870014", "K770154", "K864115", "K791806", "K893406", "K842666", "K955433", "K781854" ], "registration_number": [ "3013764800", "3009493875", "3003730855", "3003627840", "3008048800", "3012494290", "3010308146", "2032677", "3033796310", "3005334138", "3033858895", "1828424", "3009211636", "3013666218", "1417485", "3005012805", "3018094310", "3009381954", "1911916", "2648727", "1019003", "1450662", "1054241", "9610612", "1724474", "3013666336", "3004605321", "1048735", "3009039068", "3042261306", "2032112", "3010170586", "8022210", "9681260", "2030624", "3008719017", "3004472854", "3013909820", "3017103427", "9612030", "2029015", "3017264244", "2320762", "3005034064", "3007695959", "3015495690", "3043141270", "3006542380", "3024891479", "3023657851", "3003902679", "3008693678", "3008258694", "1928237", "3009171251", "3004111573", "8040278", "3010546717", "1219536", "2032098", "3012341425", "3015924373", "1054811", "3008850249", "3010034780", "3010882065", "3008102042", "1721676", "1062154", "2011171", "1723241", "1645337", "2084346", "2124215", "1061124", "2916714", "1921846", "1722095", "3033589330", "2028924", "3043619925", "9616991", "3011642792", "3015173212", "3004112621", "3012568936", "1644312", "1713468", "3003528228", "2125050", "9610849", "3010131137", "3020460367", "3017636737", "3014586728", "8031007", "1123010", "3011175548", "2028523", "3015309643", "3006973666", "1123137", "1836161", "8010607", "9616088", "3003915875", "1423507", "3016171914", "2182979", "1825146", "3012536737", "3005726841", "1423537", "3012421607", "1423395", "3044883001", "3007007790", "9616086", "3007830707", "3016734145", "3008806809", "3014615028", "3032534", "3006697110", "3005448067", "3006174295", "3010432890", "1000121056", "3012101947", "2523676", "1000563940", "1625425", "1043214", "3004859241", "1643817", "3014827316", "3011219572", "1416980", "3005580113", "3010041511", "2032809", "3004116032", "9610825", "2183744", "3045058049", "9617594", "1721504", "3030511423", "3010594263", "3007305485", "1047843", "1018470", "1119779", "3006950086", "2183425", "3008132398", "3004911384", "3030574705", "1424263", "3005533873", "1828132", "3034669683", "8030607", "3022320321", "3004519921", "3008307705", "3015859709", "8044099", "3009747810", "3011707784", "9681129", "1723170", "9611112", "3006260740", "1055236", "3011987967", "3005669815", "3006673317", "3011137372", "3027454635", "1649395", "3007699067", "3006425876", "3006554912", "3015058854", "1450395", "3018116884", "3033536312", "2521402", "9614279", "3013298431", "3004530184", "3005273623", "3004122598", "3017102971", "3007544634", "3035708926", "9617192", "3012833053", "1319639", "3017262662", "1422634", "3015225571", "9680794", "3004365956", "8022978", "3008573567", "3026310731", "9611665", "3009308092", "3005595283", "3045816902", "2027804", "1820334", "3032028815", "3006142527" ], "fei_number": [ "3013764800", "3009493875", "3003730855", "3003627840", "3008048800", "3012494290", "3010308146", "3003076831", "3003015552", "1000123297", "3005334138", "3033796310", "3009211636", "1000160458", "1417485", "3013666218", "3018094310", "3009381954", "3005012805", "1911916", "2648727", "1019003", "1450662", "1048735", "3013666336", "3004605321", "3009039068", "3042261306", "3010170586", "3002798689", "3008719017", "3004472854", "3013909820", "3017103427", "3017264244", "3005034064", "3007695959", "3015495690", "3002806565", "3005747797", "3006542380", "3002807095", "1000117748", "3043141270", "3024891479", "1000118360", "3023657851", "1000517638", "3003902679", "3008693678", "3008258694", "1928237", "3004111573", "3010546717", "1219536", "3012341425", "3015924373", "3008850249", "1000138054", "3010034780", "3007573441", "1721676", "2011171", "2124215", "1000514656", "2916714", "1921846", "3033589330", "3043619925", "3011642792", "3006582718", "3015173212", "3002565916", "3008002452", "3004112621", "3012568936", "5637", "1713468", "3003528228", "3033858895", "3006759904", "3003040625", "2125050", "3002806469", "3010131137", "3020460367", "3003767881", "3004458261", "3005846326", "3004169154", "3017636737", "3014586728", "1000117278", "3008782585", "3011175548", "3002807091", "3015309643", "1000112877", "3006973666", "3003094851", "3003915875", "3000215000", "3016171914", "2182979", "1825146", "3012536737", "3005726841", "3012421607", "3005596530", "3044883001", "3002807391", "3007007790", "3002750084", "3007830707", "3016734145", "3008806809", "3014615028", "3006697110", "3005448067", "3002902735", "3006174295", "3010432890", "1000121056", "3012101947", "2523676", "3001236905", "1000563940", "3002924544", "1625425", "1043214", "3004859241", "3932", "1643817", "3014827316", "3011219572", "1416980", "1000517719", "3005580113", "3010041511", "1000125732", "1000512168", "3004116032", "2183744", "3045058049", "3003945344", "3002806315", "1721504", "1000114185", "3030511423", "3010594263", "3002806934", "1047843", "3007305485", "1018470", "1119779", "3006950086", "2183425", "3003807466", "3004911384", "3030574705", "1828424", "3005533873", "1828132", "3003058448", "3022320321", "3034669683", "1000142697", "3008307705", "3015859709", "1000125147", "3009747810", "3011707784", "3000717925", "3011308139", "3006260740", "3011987967", "1000123180", "3005669815", "1000112968", "3004216008", "3006076154", "1000124817", "3027454635", "3007699067", "3006097687", "3006425876", "3006554912", "3015058854", "1450395", "3018116884", "3033536312", "2521402", "3032028815", "3013298431", "3004530184", "3005273623", "3004122598", "3000718472", "3017102971", "3003205539", "3007544634", "3035708926", "3012833053", "3017262662", "3003737899", "3015225571", "3004365956", "3008573567", "3026310731", "3009308092", "3005595283", "3045816902", "3006509795", "1820334", "3000206435", "3006142527" ], "device_name": "Accessories, Catheter", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4200", "device_class": "1" } } ] }