Recall Z-2220-2025 — 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 heart
U.S. FDA — Device Enforcement · France · 2025-03-13 · Class II
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Reported risk: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
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