# FDA recall Z-2220-2025

> **INSTITUT GEORGES LOPEZ** · Class II · device recall initiated 2025-03-13.

## 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 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

## Reason for recall

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

## Distribution

International distribution to the country of France.

## Key facts

- **Recall number:** Z-2220-2025
- **Recalling firm:** INSTITUT GEORGES LOPEZ
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-13
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** ST LAURENT DE CHAMOUSSET, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2220-2025

## Citation

> AI Analytics. FDA recall Z-2220-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2220-2025. Source: US FDA. Licensed CC0.

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