Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog

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: 602 kits Lot/code info: 1) SEN73NSKCF, UDI-DI: 10888439509304(each), 50888439509302(case), Lot Number: 3024-2 ; 2) SNE30CNOHE, UDI-DI: 10195594506230(each), 50195594506238(case), Lot Number: 93845 ; 3) SNE30CRJGY, UDI-DI: 10195594453992(each), 50195594453990(case), Lot Number: 4730 ; 4) SNE43NEE13, UDI-DI: 10198956470965(each), 50198956470963(case), Lot Number: 14039 ; 5) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 6033 ; 6) SNE5CLPB12, UDI-DI: 10197106266687(each), 50197106266685(case), Lot Number: 4366 ; 7) SNE5CLPB13, UDI-DI: 10197106328132(each), 50197106328130(case), Lot Number: 7390 ; 8) SNE69PSKR4, UDI-DI: 10197106895580(each), 50197106895588(case), Lot Number: 13673 ; 9) SNE7CSHY15, UDI-DI: 10197106979006(each), 50197106979004(case), Lot Number: 13673 ; 10) SNE7CSHY16, UDI-DI: 10198956026582(each), 50198956026580(case), Lot Number: 14813 ; 11) SOP30ODSCL, UDI-DI: 10197106705599(each), 50197106705597(case), Lot Number: 14813

UPC codes

10888439509304, 50888439509302, 10195594506230, 50195594506238, 10195594453992, 50195594453990, 10198956470965, 50198956470963, 10197106266687, 50197106266685, 10197106328132, 50197106328130, 10197106895580, 50197106895588, 10197106979006, 50197106979004, 10198956026582, 50198956026580, 10197106705599, 50197106705597

Source

Official record: FDA (Device enforcement) ↗

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