Device product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Z-0565-2024
Product summary
- Firm
- CardioQuip, LLC
- Event
- Event 93446
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-0565-2024
Official wording
Reason: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Code information: UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
Distribution pattern: US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Derived failure modes
-
Microbial contamination
bacterial contamination