CardioQuip Modular Cooler-Heater heating chamber malfunction poses burn risk
CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.
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: This is an FDA Class II recall without reported hospitalizations or injuries. The hazard is a potential heating-chamber malfunction with theoretical risk of burning or melting internal components. Per the rubric, risk-of-harm products without reported injury score High (3).
Plain-English summary
CardioQuip, LLC is recalling approximately 150 units of the CardioQuip Modular Cooler-Heater, Model MCH-1000(m) (115V, 60Hz, 16A). The device is a medical-grade temperature control unit used in clinical and healthcare settings.
The FDA has identified a potential malfunction in the heating chamber that could result in melting or burning of internal heater chamber components. This malfunction could create a fire hazard or thermal injury risk during operation.
The recalled devices have been distributed across 15 U.S. states including Texas, Indiana, Illinois, Wisconsin, Florida, New Jersey, Pennsylvania, Kentucky, Virginia, West Virginia, Connecticut, California, Washington, Alabama, and Iowa. Specific serial numbers for the affected units are listed in the FDA recall notice.
Healthcare facilities that have received this device should immediately stop using it and contact CardioQuip, LLC or the FDA for replacement or corrective action instructions. Do not operate the device until repair or replacement instructions have been provided by the manufacturer.
The recalled product
- Product
- CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
- Manufacturer
- CardioQuip, LLC
- Affected units
- 150
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)00860000846110/Serial Numbers: 11160203
- 11160204
- 11160315
- 11160316
- 11160317
- 11160318
- 11160319
- 11160320
- 11161109
- 11161832
- 11161836
- 11161837
- 11161838
- 11161839
- 11160216
- 11160217
- 11160218
- 11160548
- 11160549
- 11160550
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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