# FDA recall Z-0565-2024

> **CardioQuip, LLC** · Class II · device recall initiated 2023-10-24.

## Product

CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A

## Reason for recall

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

## Distribution

US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None

## Key facts

- **Recall number:** Z-0565-2024
- **Recalling firm:** CardioQuip, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-24
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** College Station, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2024

## Citation

> AI Analytics. FDA recall Z-0565-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0565-2024. Source: US FDA. Licensed CC0.

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