Medical cooler-heater device recalled for inadequate maintenance and inspection guidance
CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.
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: FDA Class II recall for missing maintenance and inspection guidance with no reported illnesses or injuries. This labeling deficiency is a precautionary correction under FDA standards.
Plain-English summary
CardioQuip, LLC is recalling 1,646 units of the Modular Cooler-Heater 1000(m) medical device. The device is used in healthcare settings for temperature control applications. The FDA issued this recall due to inadequate product labeling that does not include proper guidance for water-quality maintenance and device inspection procedures.
Without adequate maintenance instructions, users may not properly maintain water quality or perform necessary inspections of the device. This could result in device malfunction or undetected problems that affect the device's performance and safety.
The affected devices have been distributed worldwide, including all U.S. states and territories, as well as internationally in Germany, The Bahamas, Panama, and Uruguay. All serial numbers of the model MCH-1000(m) are included in this recall.
The recalled product
- Product
- CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
- Manufacturer
- CardioQuip, LLC
- Hazard
- inadequate-labeling
- improper-maintenance
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
Distributed nationwide across the United States.
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