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 Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECT
Cardinal Health 200, LLC
The hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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 Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) SEN73NSKCFModel UDI-DI: 10888439509304(each)Model 50888439509302(case)Model Lot Number: 3024-2Model 2) SNE30CNOHEModel UDI-DI: 10195594506230(each)Model 50195594506238(case)Model Lot Number: 93845Model 3) SNE30CRJGYModel UDI-DI: 10195594453992(each)Model 50195594453990(case)Model Lot Number: 4730Model 4) SNE43NEE13Model UDI-DI: 10198956470965(each)Model 50198956470963(case)Model Lot Number: 14039Model 5) SNE5CLPB12Model UDI-DI: 10197106266687(each)Model 50197106266685(case)Model Lot Number: 6033Model 6) SNE5CLPB12Model Lot Number: 4366Model 7) SNE5CLPB13UPC 10888439509304UPC 50888439509302UPC 10195594506230UPC 50195594506238UPC 10195594453992UPC 50195594453990UPC 10198956470965UPC 50198956470963UPC 10197106266687UPC 50197106266685UPC 10197106328132UPC 50197106328130UPC 10197106895580UPC 50197106895588UPC 10197106979006UPC 50197106979004UPC 10198956026582UPC 50198956026580UPC 10197106705599UPC 50197106705597Would you have heard about this one?
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