Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0038-2022 — CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

U.S. FDA — Device Enforcement · United States · 2021-05-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0038-2022
Date of alert
2021-05-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CardioQuip, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860000846134
Reported risk: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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