Celsior Storage Solution (Institut Georges Lopez) – contamination risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 wit
Brand
INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France is recalling Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog due to The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026