Recall Z-0566-2024— CardioQuip, LLC
Class II · Ongoing
Class II FDA medical device recall by CardioQuip, LLC, initiated 2023-10-24. It names one FDA 510(k) clearance: K102147. Product: CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A. Reason: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection..
- Recalling firm
- CardioQuip, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-24
- Firm location
- College Station, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Reason for recall
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.