CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction
CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.
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: The recall involves a potential safety hazard—heating chamber malfunction could cause melting and burning of internal components—that poses a risk of burn injury or fire. Per the severity rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' corresponding to High (3) severity. No illnesses or injuries have been reported.
Plain-English summary
CardioQuip, LLC is recalling 125 units of the CardioQuip Modular Cooler-Heater, Model MCH-1000(i), Power 115V-60hz, 16A due to a potential heating-chamber malfunction. The heating chamber could malfunction, resulting in melting and burning of the heater chamber components.
The recalled units have been distributed to healthcare facilities across 15 US states: Texas, Indiana, Illinois, Wisconsin, Florida, New Jersey, Pennsylvania, Kentucky, Virginia, West Virginia, Connecticut, California, Washington, Alabama, and Iowa. Consumers can identify their unit using the serial numbers provided in the official FDA recall notice.
Consumers who own or operate affected units should immediately stop using the device and contact CardioQuip, LLC. Do not attempt to use or repair the device. For a full list of affected serial numbers and next steps, refer to the FDA recall notice.
The recalled product
- Product
- CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
- Manufacturer
- CardioQuip, LLC
- Affected units
- 125
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 (20)
- UDI: (01)00860000846103/ Serial Numbers: Serial Numbers: 10160461
- 10160463
- 10160465
- 10160466
- 101060467
- 10160468
- 10161406
- 10161408
- 10161553
- 10161689
- 10160275 1016276
- 1016277
- 10160274
- 10161065
- 10161066
- 10160825
- 10160826
- 10160827
- 10160828
- 10161140
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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FDA (Devices) · 2021-10-13
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