Cardioquip Modular Cooler-Heater Model Mch-1000

510(k) K102147

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK102147	Date19 Nov 2010Cleared	StatusActive

9 recalls · 9 ongoing · FDA

2 recalls, same reason
- Ongoing Z-0565-2024 FDA Class II initiated 24 Oct 2023
- Ongoing Z-0566-2024 FDA Class II initiated 24 Oct 2023
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
2 recalls, same reason
- Ongoing Z-0439-2024 FDA Class II initiated 19 Oct 2023
- Ongoing Z-0438-2024 FDA Class II initiated 19 Oct 2023
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- Ongoing Z-0069-2022 FDA Class II initiated 24 Jun 2021
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
4 recalls, same reason
- Ongoing Z-0038-2022 FDA Class II initiated 12 May 2021
- Ongoing Z-0037-2022 FDA Class II initiated 12 May 2021
- Ongoing Z-0036-2022 FDA Class II initiated 12 May 2021
- Ongoing Z-0035-2022 FDA Class II initiated 12 May 2021
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

1 jurisdiction

United States — FDA 510(k) Active

510(k)