Question 1

Is 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 recalled?

Accepted Answer

INSTITUT GEORGES LOPEZ has recalled 1,532 units of Celsior Cold Storage Solution (Model 533682) due to manufacturing issues that could compromise the product's sterility. This solution is specifically used by medical professionals for flushing and storing donor hearts during the transplantation process. While no injuries or infections have been reported, the manufacturer is recalling specific batches to prevent potential patient harm.

Question 2

What should I do?

Accepted Answer

This recall affects Celsior Cold Storage Solution (Model 533682), which is used for the hypothermic flushing and storage of hearts during transportation for transplantation. Identify affected products by checking for the following lot numbers: SL240261-1, SL240266-1, SL240272-1, or SL240280-2. In the United States, you may also check the Unique Device Identifier (UDI) on the carton box (23700911900123) or the UDI on the bag (13700911900126) for reference, though affected batches were primarily distributed in France. Stop using the recalled product immediately. Contact the manufacturer or your distributor to arrange return, replacement, or correction of any affected units. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Question 3

How do I get a refund or replacement?

Accepted Answer

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Celsior Cold Storage Solution Recalled for Potential Sterility Failure

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?