Recall Z-0565-2024 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
| Date | Dec 15, 2023 (initiated Oct 24, 2023) |
| Status | Open, Classified |
| Reason | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
| Root cause | Process control |
| Action | 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 po |
| Quantity | 4 units |
| Distribution | US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None |
| 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 |