Z-1327-2025 Class II Ongoing
FDA device recall Z-1327-2025 was initiated by Spectrum Medical Inc on January 16, 2025 and is designated Class II. Reason for recall: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. The recall status is ongoing. Affected quantity: 1487 unit.
Recall Details
- Product Type
- Devices
- Report Date
- March 19, 2025
- Initiation Date
- January 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1487 unit
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
Reason for Recall
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
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.
Code Information
Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511