Z-0565-2024 Class II Ongoing
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