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 PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 6928769 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7160527 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7163103 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7280105 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332911 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332915 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7160537 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7331341 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7332910 ; Catalog Number PE23SENLC, UDI/DI 10197106760956 (EA)50197106760954 (CS), Lot Number 7332917 ; Catalog Number PE30EAGT6, UDI/DI 10195594668167 (EA)50195594668165 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT7, UDI/DI 10195594725600 (EA)50195594725608 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT8, UDI/DI 10195594774950 (EA)50195594774958 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT9, UDI/DI 10197106038192 (EA)50197106038190 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D123
10197106461914, 50197106461912, 10197106644829, 50197106644827, 10197106543351, 50197106543359, 10197106760956, 50197106760954, 10195594668167, 50195594668165, 10195594725600, 50195594725608, 10195594774950, 50195594774958, 10197106038192, 50197106038190, 10887488998749, 50887488998747, 10197106667309, 50197106667307, 10197106733622, 50197106733620, 10195594540302, 50195594540300, 10195594565909, 50195594565907, 10197106027165, 50197106027163, 10197106236963, 50197106236961, 10197106285398, 50197106285396, 10197106310618, 50197106310616, 10197106322390, 50197106322398, 10197106365939, 50197106365937, 10197106418710, 50197106418718
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.