Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmo
FDA device recall Z-1327-2025 · posted 2025-03-13 · Open, Classified
Recall details
- Recalling firm
- Spectrum Medical Inc
- Reason for recall
- Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KFM
- Quantity affected
- 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, Mary
- Date initiated
- 2025-01-16
- Date posted
- 2025-03-13
- Location
- Fort Mill, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (K201320) | Qura S.R.L | 2021-11-03 |