Recall archive / FDA device enforcement
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A — FDA record Z-0565-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- CardioQuip, LLC
- Quantity
- 4 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0565-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Oct 24, 2023
- Center classification date
- Dec 15, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.