Z-2220-2025Class II

Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number...

Name: Z-2220-2025 Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number...
Creator: Institut Georges Lopez
Published: 2025-03-13
License: https://open.fda.gov/license/

Institut Georges Lopez / initiated 2025-03-13 / Open, Classified / root cause: sterility

FDA source

INSTITUT GEORGES LOPEZ began a recall of Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a... on 2025-03-13. FDA classified it as Class II and gives the reason as "The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2220-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-13
Posted: 2025-07-30
Recalling firm: Institut Georges Lopez
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 46F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
Product code: MSB System And Accessories, Isolated Heart, Transport And Preservation
Reason for recall: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On March 13, 2025 notification emails were sent to OUS customers informing them of the recall and instructing them to check their inventory for affected product and to destroy it. If they did not wish to destroy, to arrange for the product to be returned to the recalling firm. Customers were instructed to acknowledge receipt of the email and provide proof of destruction, if performed.
Quantity in commerce: 1,532 units
Distribution: International distribution to the country of France.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2220-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2220-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-30

Product code MSB

K991594Class IICelsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. / cleared 1999-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)