INSTITUT GEORGES LOPEZ: Device Recall
Recall #Z-2220-2025 · 03/13/2025
Recall Details
- Recall Number
- Z-2220-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- INSTITUT GEORGES LOPEZ
- Status
- Ongoing
- Date Initiated
- 03/13/2025
- Location
- ST LAURENT DE CHAMOUSSET, France
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,532 units
Reason for Recall
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Product Description
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 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
Distribution Pattern
International distribution to the country of France.