Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI O

Hazard

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Details from the source

Reason for recall: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Distribution: US Nationwide. Canada. Quantity: 401311 kits Lot/code info: 3790) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4730 ; 3791) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 2221315564 ; 3792) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 338058 ; 3793) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4869 ; 3794) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3795) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3796) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3797) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3798) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3799) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 9243-1 ; 3800) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3024-2 ; 3801) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3916-2 ; 3802) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243 ; 3803) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3804) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3805) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3806) SNE30CNRCE, UDI-DI: 10197106605233(each), 501971066

UPC codes

10195594687052, 50195594687050, 10197106605233, 50197106605231, 10198956041448, 50198956041446, 10198956043138, 50198956043136, 10198956064638, 50198956064636, 10197106893623, 50197106893621, 10197106974209, 50197106974207, 10195594610821, 50195594610829, 10197106712368, 50197106712366, 10198956110106, 50198956110104, 10198956148208, 50198956148206, 10198956148376, 50198956148374, 10197106893173, 50197106893171, 10198956031388, 50198956031386, 10198956082885, 50198956082883, 10197106008461, 50197106008469, 10198956190894, 50198956190892, 10198956026711, 50198956026719, 10198956080027, 50198956080025, 10198956010642, 50198956010640

Source

Official record: FDA (Device enforcement) ↗

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