FDAFDA · Food and drugs·Recall number Z-0566-2024
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Published December 27, 2023 · Recall initiated: October 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CardioQuip, LLC
- Distributor
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
- Lot
- UDI: 00860000846110 /Lot #:11160294 and 11161110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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