Spectrum Medical Inc: Device Recall
Recall #Z-1327-2025 · 01/16/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1327-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spectrum Medical Inc
- Status
- Ongoing
- Date Initiated
- 01/16/2025
- Location
- Fort Mill, SC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1487 unit
Reason for Recall
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Product Description
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Distribution Pattern
US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.