Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance
CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall driven by missing maintenance and inspection guidance in product labeling. No illnesses, injuries, or deaths have been reported. The hazard is a labeling deficiency rather than a device malfunction.
Plain-English summary
CardioQuip, LLC is recalling the Modular Cooler-Heater 1000(m) with Thermoelectric Cooling Lid (Model MCH-11TEC). The recalled devices were distributed worldwide, including across all U.S. states and to Germany, The Bahamas, Panama, and Uruguay. A total of 369 units are affected.
The recall is due to incomplete product labeling. The device documentation does not include proper guidance for water-quality maintenance and device inspection. This omission may prevent users from performing necessary maintenance and inspection procedures.
If you own or operate one of these devices, contact CardioQuip, LLC for guidance on proper water-quality maintenance and device inspection procedures.
The recalled product
- Product
- CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
- Manufacturer
- CardioQuip, LLC
- Affected units
- 369
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by CardioQuip, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · CardioQuip, LLC
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- HighCardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction
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- HighCardioQuip Modular Cooler-Heater Units Recalled for Bacterial Water Contamination
FDA (Devices) · 2021-10-13
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