Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catal

Hazard

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Details from the source

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 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5631070 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5530905 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5138271 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5533340 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136018 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136034 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136012 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136019 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140342 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5324034 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5138327 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140378 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5478803 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5324048 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5138335 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), L

UPC codes

10195594412845, 50195594412843, 10195594124007, 50195594124005, 10195594247867, 50195594247865, 10195594272777, 50195594272775, 10195594356156, 50195594356154, 10197106243367, 50197106243365, 10888439373196, 50888439373194, 10888439713367, 50888439713365, 10888439341782, 50888439341780, 10197106722909, 50197106722907, 10888439682618, 50888439682616, 10888439616828, 50888439616826, 10888439679359, 50888439679357, 10195594375522, 50195594375520, 10887488542829, 50887488542827, 10888439885170, 50888439885178, 10195594202040, 50195594202048, 10195594276119, 50195594276117, 10195594327347, 50195594327345, 10195594725136, 50195594725134

Source

Official record: FDA (Device enforcement) ↗

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