Spectrum Medical Inc recalls Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Prod…

Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

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

On January 16, 2025, Spectrum Medical issued a Medical Device Recall notification to affected consignees via E-Mail. Spectrum Medical asked consignees to take the following actions: 1. Send back the Spectrum Medical Inc. a copy of the "Medical Device Recall Return Response" attached with all fields completed by emailing ht

• FDA enforcement recordOfficial FDA database entry for Z-1327-2025
• FDA 510(k) clearance · K201320The device's official FDA premarket clearance record
• FDA device classification · KFMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4360The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spectrum Medical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.