CardioQuip Modular Cooler-Heater, Model: MCH-1000(m)… recallZ-0566-2024 · CardioQuip, LLC · initiated Oct 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CardioQuip, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA root cause category: Process control
What the company is doing
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:
Recall details
- Recall number
- Z-0566-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 24, 2023
- Posted by the FDA
- Dec 15, 2023
- Recalling firm
- CardioQuip, LLC
- Quantity
- 2 units
- Product code
- DWC
- FDA submissions
- K102147
- Distribution
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Product description
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Code information (models, lots, serial numbers)
UDI: 00860000846110 /Lot #:11160294 and 11161110
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(m)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls206 reports
Other devices under the same FDA submission
1 device cleared under K102147 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CardioQuip Modular Cooler-Heater (MCH) MCH-1000(i)Cardioquip, LLC · Controller, Temperature, Cardiopulmonary Bypass2 recalls334 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93446).
- Z-0565-2024 · Open, ClassifiedCardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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