Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
USCardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Recalling Firm: Cardinal Health 200, LLC
Reason for Recall / Hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Product Description & Identification
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Affected Products
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Additional Source Details
| Field | Value |
|---|---|
| City | Waukegan |
| State | IL |
| Event id | 99380 |
| Address 1 | 3651 Birchwood Dr |
| 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¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; |
| Postal code | 60085-8337 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 456 kits |
| Reason for recall | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260714 |
| Initial firm notification | Letter |
| Center classification date | 20260813 |
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Overview
- Recalling FirmCardinal Health 200, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide. Canada.
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🚨 SAFETY ALERT: Cardinal Health 200, LLC - Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC Check if your household is affected: https://therecallfile.com/recalls/cardinal-health-presource-kits-1-harmonized-spine-vch-phc-pack-catalog/FDA-Z-2943-2026
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