FDA Enforcement
Class II
Ongoing
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Recall: Z-0565-2024
·
Reported December 27, 2023
Enforcement
- Recall Number
- Z-0565-2024
- Event ID
- 93446
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CardioQuip, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 27, 2023
- Initiation Date
- October 24, 2023
- Classification Date
- December 15, 2023
- Address
- 8422 Calibration Ct, N/A, College Station, TX, 77845-5328, United States
Description
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Reason
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Code Info
UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
Distribution
US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Quantity
4 units