Modular Cooler-Heater (CardioQuip) – bacterial contamination (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Brand
CardioQuip, LLC
Lot Codes / Batch Numbers
UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
Products Sold
UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
CardioQuip, LLC is recalling CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A due to There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Recommended Action
Per FDA guidance
On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NE, OH, PA, TX, WA
Page updated: Jan 10, 2026