PlainRecalls
FDA Devices Moderate Class II Ongoing

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 b

Reported: August 6, 2025 Initiated: March 13, 2025 #Z-2220-2025

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).

Reason for Recall

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

Details

Recalling Firm
INSTITUT GEORGES LOPEZ
Units Affected
1,532 units
Distribution
International distribution to the country of France.
Location
ST LAURENT DE CHAMOUSSET

Frequently Asked Questions

What product was recalled? ▼
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).. Recalled by INSTITUT GEORGES LOPEZ. Units affected: 1,532 units.
Why was this product recalled? ▼
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 6, 2025. Severity: Moderate. Recall number: Z-2220-2025.

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