CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination
CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm medical device with potential for patient infection, but no illnesses or infections have been reported. The contamination is theoretical and unconfirmed, and the device is classified as FDA Class II rather than Class I.
Plain-English summary
CardioQuip, LLC is recalling the Modular Cooler-Heater, Model MCH-1000(i), due to the potential that devices may contain bacterial contamination which could result in patient infection.
Four units were distributed to customers in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska. Affected lot numbers are 10161316, 10161479, 10160241, and 10161040 (UDI: 00860000846103).
No illnesses or infections have been reported to date. Customers who have received an affected unit should contact CardioQuip, LLC for further information regarding this recall.
The recalled product
- Product
- CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
- Manufacturer
- CardioQuip, LLC
- Category
- Medical Device
- Hazard
- Affected units
- 4
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 (4)
- UDI: 00860000846103 /Lot #:10161316
- 10161479
- 10160241
- 10161040
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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