Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Produ
FDA device recall Z-2220-2025 · posted 2025-07-30 · Open, Classified
Recall details
- Recalling firm
- INSTITUT GEORGES LOPEZ
- Reason for recall
- The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
- Action taken
- On March 13, 2025 notification emails were sent to OUS customers informing them of the recall and instructing them to check their inventory for affected product and to destroy it. If they did not wish to destroy, to arrange for the product to be returned to the recalling firm. Customers were instructed to acknowledge receipt of the email and provide proof of destruction, if performed.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MSB
- Quantity affected
- 1,532 units
- Distribution
- International distribution to the country of France.
- Date initiated
- 2025-03-13
- Date posted
- 2025-07-30
- Location
- ST LAURENT DE CHAMOUSSET, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594) | Sangstat Medical Corp. | 1999-08-05 |