Z-0566-2024 Class II Ongoing
FDA device recall Z-0566-2024 was initiated by CardioQuip, LLC on October 24, 2023 and is designated Class II. Reason for recall: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. The recall status is ongoing. Affected quantity: 2 units.
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
- 2 units
Product Description
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), 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: 00860000846110 /Lot #:11160294 and 11161110