Z-2943-2026Class II
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Medtronic, Inc. / initiated 2026-07-14 / Open, Classified / root cause: manufacturing process
Cardinal Health 200, LLC began a recall of Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC on . FDA classified it as Class II and gives the reason as "Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2943-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
- Product code
- OFQ Anesthesia Kit
- Reason for recall
- Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Cardinal Health issued an URGENT: PRODUCT CORRECTION notice to its consignees on 7/14/2026 via FedEx. The notice explained the issue and enclosed a copy of the recall notice issued by the supplier of the affected component which explained the risk and provided details on the affected component. The notice issued by Cardinal Health requested that consignee notify its clinicians, affix a warning label to the affected kits in their inventory, and respond using the acknowledgement form via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: [email protected]. The warning label requests that the affected component be removed and discarded. For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166. Distributors were direct to notify their customers. For questions, additional labels, or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
- Quantity in commerce
- 456 kits
- Distribution
- US Nationwide. Canada.
- Product codes and lots
- 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¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2942-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2943-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2944-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2945-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2946-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2947-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2948-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2949-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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