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 PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ;
10888439692228, 50888439692226, 10888439821260, 50888439821268, 10197106435052, 50197106435050, 10197106646724, 50197106646722, 10197106673195, 50197106673193, 10197106713365, 50197106713363, 10197106718834, 50197106718832, 10888439940176, 50888439940174, 10195594331474, 50195594331472, 10195594505493, 50195594505491, 10195594555559, 50195594555557, 10195594646134, 50195594646132, 10195594697884, 50195594697882, 10197106129982, 50197106129980, 10197106188095, 50197106188093, 10197106329771, 50197106329779, 10888439749526, 50888439749524, 10888439983265, 50888439983263, 10195594714352, 50195594714350, 10197106473740, 50197106473748
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.