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Open, Classified

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

FDA Recall Z-0565-2024 · Posted 2023-12-15

Recalling FirmCardioQuip, LLC
Recall StatusOpen, Classified
Product CodeDWC
Date Initiated2023-10-24
Product Quantity4 units

Reason for Recall

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

Firm Action

On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp · 2010-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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