CardioQuip Cooler-Heater Device Lacks Water-Quality and Inspection Guidance
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. Missing maintenance guidance for a medical device used in healthcare settings constitutes a risk-of-harm situation even without reported adverse events, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CardioQuip Modular Cooler-Heater 1000(i) devices (Model MCH-10RMS, UDI 00860000846127) are subject to this FDA Class II recall. Approximately 1,380 units have been distributed worldwide, including across all U.S. states and territories, as well as Germany, The Bahamas, Panama, and Uruguay.
The devices' labeling fails to provide necessary guidance on proper water-quality maintenance and device inspection procedures. This omission prevents users from understanding critical operational requirements for maintaining device safety and performance.
Healthcare facilities and other users of affected devices should immediately contact CardioQuip, LLC to obtain proper maintenance and inspection guidance. Users should ensure they have comprehensive instructions for water-quality management and device inspection before continuing operation.
The recalled product
- Product
- CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
- Manufacturer
- CardioQuip, LLC
- Hazard
- mis-labeling
- missing-maintenance-guidance
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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