CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
FDA device recall Z-0438-2024 · posted 2023-12-01 · Open, Classified
Recall details
- Recalling firm
- CardioQuip, LLC
- Reason for recall
- There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
- Action taken
- 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. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. 5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DWC
- Quantity affected
- 150 units
- Distribution
- US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
- Date initiated
- 2023-10-19
- Date posted
- 2023-12-01
- Location
- College Station, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |