Z-0565-2024 Class II Ongoing

Recalled by CardioQuip, LLC — College Station, TX

Recall Details

Product Type
Devices
Report Date
December 27, 2023
Initiation Date
October 24, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

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 Pattern

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

Code Information

UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040