CardioQuip — Class II medical device recall Z-0069-2022
Ongoing recall by CardioQuip, LLC, reported 2021-10-13, distributed nationwide. There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of h
| Recall number | Z-0069-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioQuip, LLC, College Station, TX, United States |
| Recall initiated | 2021-06-24 |
| Classified | 2021-10-07 |
| Reported by FDA | 2021-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | VE |
| Quantity | 1,380 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00860000846127 |
| Model numbers | MCH-10RMS |
Product
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Reason for recall
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0069-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.