Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr
Summary
The FDA issued a Class II for Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage So by INSTITUT GEORGES LOPEZ. Reason: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing..
Details
Source
Device Recall
External ID
Z-2220-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
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).
Lot/Code Info: 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
Quantity Affected: 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.
Distribution
International distribution to the country of France.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-13
Company
ST LAURENT DE CHAMOUSSET
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
INSTITUT GEORGES LOPEZ has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (INSTITUT GEORGES LOPEZ) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INSTITUT GEORGES LOPEZ have FDA actions?
INSTITUT GEORGES LOPEZ has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2220-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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