Recall Z-0439-2024 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
| Date | Dec 1, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components. |
| Root cause | Device Design |
| Action | On 10/19/23, CardioQuip issued a "Urgent: Medical Device Correction" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication. CardioQuip ask consignees to take the following actions: 1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use. 2.Never operate the device dry (see communication for further details). 3. Design Changes to be implemented (see communication for further details). A. Relocation of the water Level Sensor (see communication for further details). B. Software Update (see communication for further details). 4. Ple |
| Quantity | 125 units |
| Distribution | US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 Cardioquip Llp, Nov 19, 2010 |