Recall Z-1327-2025 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Spectrum Medical Inc
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
| Date | Mar 13, 2025 (initiated Jan 16, 2025) |
| Status | Open, Classified |
| Reason | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 1487 unit |
| 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 C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor Qura S.R.L, Nov 3, 2021 |