FDA Medical devices recall ·
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors… recall
- Recall number
- Z-1327-2025
- Date
- (initiated January 16, 2025)
- Company / brand
- Spectrum Medical Ltd.
481 Munn Rd Ste 250, Fort Mill, SC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1487 unit
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511
Distribution
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.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Missouri Mississippi New York Ohio Oregon Pennsylvania South Carolina Tennessee Texas Utah Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1327-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.