CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
FDA device recall Z-0565-2024 · posted 2023-12-15 · Open, Classified
Recall details
- Recalling firm
- CardioQuip, LLC
- Reason for recall
- There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
- Action taken
- 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:
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DWC
- Quantity affected
- 4 units
- Distribution
- US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
- Date initiated
- 2023-10-24
- Date posted
- 2023-12-15
- Location
- College Station, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |