During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
Reason for recall: During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile. Distribution: Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates. Quantity: 1,873 units Lot/code info: REF Model Numbers/NSO Item #/Product Description/UDI-DI Code: MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard / 812258022624 Lot Numbers: 0013101BAB 2091504AAA 8091013BAB 8121214BAD 9031814BAB 9061902BAB 2082304AAA 8060409BAB 8092007BAB 8121312BAB 9032005BAB 9061911BAB 2082306AAA 8060601BAB 8092102BAB 8121406BAB 9032006BAB 9061912BAB 2082309AAA 8061921BAB 8092404BAB 8121406BAC 9032006BAC 9061912BAC 2082412AAA 8070615BAB 8100410BAB 9010806BAB 9032007BAB 9062018BAB 2091201AAA 8070902BAB 8100410BAC 9011803BAB 9032007BAC 9062411BAB 2091202AAA 8071213BAB 8111306BAB 9011803BAC 9032014BAB 9062412BAB 2091211AAA 8071706BAB 8111415BAB 9020405BAB 9032101BAB 9062412BAC 2091212AAA 8072105BAB 8121109BAB 9021216BAB 9032102BAB 9062413BAB 2091303AAA 8082313BAB 8121109BAC 9021302BAB 9051011BAC 9062508BAB 2091304AAA 8082401BAB 8121111BAB 9021306BAB 9051016BAB 9062517BAB 2091312AAA 8082410BAB 8121205BAB 9022204BAB 9051016BAC 9062519BAB 2091314AAA 8082701BAB 8121211BAB 9022204BAC 9061812BAB 9062520BAB 2091403AAA 8082814BAB 8121214BAB 9022204BAD 9061819BAB 9062702BAB 2091405AAA 8090709BAB 8121214BAC 9031107BAB 9061901BAB 9072313BAB 9072314BAB 9081307BAB 9090931BAC 9091002BAB 9121635BAB 9121719BAB 9072516BAB 9081312BAB 9090956BAB 9093010BAB 9121711BAB 9072601BAB 9090930BAB 9090956BAC 9111222BAB 9121712BAB 9080301BAB 9090931BAB 9091001BAB 9112013BAB 9121713BAB MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard / 812258022662 Lot Numbers: 0010620BAB 8070512BAB 9071302BAB 9090410BAC
812258022624, 812258022662, 812258022709, 812258022631, 812258022679, 812258022716, 812258022600, 812258022648, 812258022686, 812258022617, 812258022655, 812258022693, 81225809265, 81225809272, 81225809296, 81225809289
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.