Recall Z-1327-2025— Spectrum Medical Inc
Class II · Ongoing
Class II FDA medical device recall by Spectrum Medical Inc, initiated 2025-01-16. It names one FDA 510(k) clearance: K201320. 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. Reason: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures..
- Recalling firm
- Spectrum Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-16
- Firm location
- Fort Mill, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.