Celsior Cold Storage Solution recalled for potential sterility assurance failure
INSTITUT GEORGES LOPEZ has recalled 1,532 units of Celsior Cold Storage Solution, a sterile solution used to preserve hearts for transplantation, due to potential microbiological contamination from manufacturing defects. The affected lots were distributed in France.
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: This is a Class II medical device recall with no reported illnesses or injuries. However, the product is used in a high-risk context (organ preservation for heart transplantation), and microbiological contamination poses serious potential harm to transplant recipients. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Celsior Cold Storage Solution is a sterile, non-pyrogenic solution manufactured by INSTITUT GEORGES LOPEZ and classified by the FDA as a Class II medical device. It is used for hypothermic flushing and storage of donor hearts in preparation for transplantation.
The recall affects 1,532 units distributed to France across multiple lot codes (SL240261-1, SL240266-1, SL240272-1, SL240280-2). The manufacturer was unable to ensure sterility assurance throughout the aseptic manufacturing process, creating a potential for microbiological contamination of the product. Contaminated solution could render organs unsuitable for transplantation or pose risks to recipients.
Organ preservation centers and transplant facilities that received the affected lots should immediately discontinue use. No illnesses or injuries have been reported to date. Healthcare providers should contact INSTITUT GEORGES LOPEZ for guidance on handling affected stock and verification of lot numbers.
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
- microbiological-contamination
- sterility-failure
Distribution
Distribution scope not specified by the agency.
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