Device recall
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
- Recall number
- Z-2943-2026
- 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
- 456 kits
- Code info
- 1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;
- Distribution
- US Nationwide. Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States