Recall Z-0565-2024
CardioQuip, LLC · initiated October 24, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Codes / lots: UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040
Reason for recall
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA-determined cause: Process control
Action taken
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:
Details
- Recall number
- Z-0565-2024
- Initiated
- October 24, 2023
- Posted by FDA
- December 15, 2023
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Quantity
- 4 units
- Distribution
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
- Recalling firm
- CardioQuip, LLC, College Station, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0566-2024 Class II | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16AThere is the potential that cooler-heater devices may contain bacterial contamination which could result in… | 10/24/2023Open, Classified |