Celsior cold storage solution recalled over sterility assurance during aseptic manufacturing
Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a sterile solution with no assurance of sterility from its aseptic manufacturing process, with no contamination reported in the source.
Plain-English summary
Celsior Cold Storage Solution, catalog number 533682, a clear to slightly yellow sterile solution classified in the US as a class II medical device, is being recalled. The action covers 1,532 units, UDI 23700911900123 for the carton box and 13700911900126 for the bag.
The stated reason is the potential for risk of microbiological contamination of products due to an inability to ensure sterility assurance throughout aseptic manufacturing. The FDA classified the action as Class II. The source does not report any contamination having been found.
Distribution was international, to France.
Facilities should identify affected stock using the catalog number and UDI codes above and follow the instructions issued by the manufacturer.
The recalled product
- 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
- Manufacturer
- INSTITUT GEORGES LOPEZ
- Hazard
- sterility-assurance
- aseptic-manufacturing
- microbiological-contamination
- class-ii
Distribution
Distribution scope not specified by the agency.
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