Cardinal Health Presource kits recalled for endotoxin variability
Cardinal Health is recalling certain Presource procedure kits because they contain MEDICOM Ritmed Neurological Sponges, which were recalled for unexpected variability in endotoxin levels. The recall covers 602 kits distributed across the US and to Canada. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Check the catalog and lot numbers in the recall notice against your kit inventory.
- Do not use kits that match the listed catalog and lot numbers.
- Contact Cardinal Health or your healthcare facility for instructions on returning or disposing of affected kits.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (under 100 years)
This recall covers 8 products — see all of them.
Details
- Units affected
- 602 kits
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, IL, United States
- Classification
- Class II
- Recall number
- Z-2946-2026
In the FDA's words
- Description
- 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 Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. 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 Distribution: US Nationwide. Canada. Affected quantity: 602 kits
- Hazard
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
8 products in this recall
Cardinal Health Presource kits recalled for endotoxin variability
Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3…Z-2942-2026 · 36862 kits
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCCZ-2943-2026 · 456 kits
- Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBZ-2944-2026 · 80 kits
- Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA;…Z-2945-2026 · 87182 kits
- Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE… (this page)Z-2946-2026 · 602 kits
- Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28…Z-2947-2026 · 401311 kits
- Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4…Z-2948-2026 · 52699 kits
- Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPH…Z-2949-2026 · 616 kits
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