FDA Medical devices recall ·
Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution… recall
- Recall number
- Z-2220-2025
- Date
- (initiated March 13, 2025)
- Company / brand
- Institut Georges Lopez
6 ROUTE DE SAINT BONNET, ST LAURENT DE CHAMOUSSET, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,532 units
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
Why was it recalled?
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI carton box: 23700911900123 & UDI bag: 13700911900126 (for US reference). The product reference recalled in France is different and there is no UDI on this one (not required for medicine in France). Batches concerned by the recall are the following: Lot SL240261-1 Lot SL240266-1 Lot SL240272-1 Lot SL240280-2 These batches have been sold only in France
Distribution
International distribution to the country of France.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2220-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.