CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination
CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
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 classification with potential bacterial contamination in a medical device creates risk of patient infection. However, no illnesses or hospitalizations have been reported, and the hazard is theoretical, placing this at High severity per the rubric.
Plain-English summary
CardioQuip LLC is recalling 2 units of the CardioQuip Modular Cooler-Heater, Model MCH-1000(m) (115V-60Hz, 16A). The recalled devices are identified by UDI 00860000846110 and lot numbers 11160294 and 11161110.
The devices may contain bacterial contamination, which could result in patient infection.
The affected devices have been distributed to medical facilities in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
The recalled product
- Product
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
- Manufacturer
- CardioQuip, LLC
- Hazard
- bacterial-contamination
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)
- UDI: 00860000846110 /Lot #:11160294 and 11161110
Distribution
Distribution scope not specified by the agency.
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