Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Reason for recall: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. Quantity: 512,786 total units Lot/code info: Catalog Number SBAOCTEHH1, UDI/DI 10195594722685 (EA)50195594722683 (CS), Lot Number 21J2883 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1028 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 22D1029 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 23F1437 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18E1332 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18H2278 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 24C0535 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), Lot Number 18J2582 ; Catalog Number SBAOCTEHHA, UDI/DI 10888439551662 (EA)50888439551660 (CS), L
10195594722685, 50195594722683, 10888439551662, 50888439551660, 10195594423469, 50195594423467, 10887488074634, 50887488074632, 10197106481400, 50197106481408
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.