Recall Z-2220-2025 ยท MSB System And Accessories, Isolated Heart, Transport And Preservation
INSTITUT GEORGES LOPEZ
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation an
| Date | Jul 30, 2025 (initiated Mar 13, 2025) |
| Status | Open, Classified |
| Reason | The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1,532 units |
| Distribution | International distribution to the country of France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS Sangstat Medical Corp., Aug 5, 1999 |