Device recall
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- Recall number
- Z-2944-2026
- Event id
- 99380
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Report date
- Aug 19, 2026
- Initiated
- Jul 14, 2026
- Center classification date
- Aug 13, 2026
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Quantity
- 80 kits
- Code info
- 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
- Distribution
- US Nationwide. Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States