Vascutek, Ltd.: Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631

Hazard

Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.

Details from the source

Reason for recall: Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging. Distribution: US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA, NJ, OH, MI, DC, CO, VA, GA, IL, OR, ND, VT, MS, MA, IN, WA, AZ, MN, MD, IA, OK, MO, AL, WI, LA, AR, TN, CT, ME, NE, SC, KS, NV, KY, RI, WV, UT, MT, ID, AK, NH, DE, NM, SD, HI, WY. Quantity: 37430 Lot/code info: All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P

UPC codes

5037881166636, 5037881166858, 5037881166896, 5037881166698, 5037881166711, 5037881166681, 5037881166520, 5037881166780, 5037881166728, 5037881166605, 5037881166865, 5037881166551, 5037881166889, 5037881166933, 5037881166919, 5037881167008, 5037881166827, 5037881166513, 5037881166063, 5037881166759, 5037881166667, 5037881166643, 5037881166872, 5037881166971, 5037881166650, 5037881166674, 5037881166803, 5037881166797, 5037881166506, 5037881166841, 5037881166537, 5037881166544, 5037881167046, 5037881166742, 5037881166926, 5037881166940, 5037881166964, 5037881167015, 5037881166773, 5037881166988

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.