Recall Z-2220-2025— INSTITUT GEORGES LOPEZ

Name: FDA recall Z-2220-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-13

Class II · Ongoing

Class II FDA medical device recall by INSTITUT GEORGES LOPEZ, initiated 2025-03-13. It names one FDA 510(k) clearance: K991594. 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 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: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing..

Recalling firm: INSTITUT GEORGES LOPEZ
Classification: Class II
Status: Ongoing
Initiated: 2025-03-13
Firm location: ST LAURENT DE CHAMOUSSET, France

510(k) clearances named in this recall

1 on FDA's record

K991594 — CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTSSangstat Medical Corp.·cleared 1999-08-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.