CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
- Company
- Cardioquip, Llc
- Recall Initiated
- October 24, 2023
- Posted
- December 15, 2023
- Recall Number
- Z-0566-2024
- Quantity
- 2 units
- Firm Location
- College Station, TX
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
Lot / Code Info
UDI: 00860000846110 /Lot #:11160294 and 11161110
Root Cause
Process control
Action Taken
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: