Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Celsior Cold Storage Solution

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Celsior Cold Storage Solutionsee related information
Date Initiated by FirmMarch 13, 2025
Date PostedJuly 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2220-2025
Recall Event ID 96793
510(K)NumberK991594 
Product Classification System and accessories, isolated heart, transport and preservation - Product Code MSB
ProductBrand 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).
Code Information 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
Recalling Firm/
Manufacturer		 INSTITUT GEORGES LOPEZ
6 ROUTE DE SAINT BONNET
ST LAURENT DE CHAMOUSSET France
Manufacturer Reason
for Recall		The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce1,532 units
DistributionInternational distribution to the country of France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MSB
-
-