Class II — INSTITUT GEORGES LOPEZ
| Recalling firm | Institut Georges Lopez |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. |
| Product | 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 and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36® to 46F. In Europe Celsior is a… |
| Quantity | 1,532 units |
| Distribution | International distribution to the country of France. |
| Initiated | 2025-03-13 |
| Classified | 2025-07-30 |
| Recall number | Z-2220-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — INSTITUT GEORGES LOPEZ (Z-2220-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96793/
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