FDAMarch 13, 2025device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

2370091190012313700911900126

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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