Blood Pump Recalled for Potential Fluid Leakage During Clinical Use
Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or incidents. The recalled blood pump is used in critical cardiac surgery where fluid leakage could pose risk, but this hazard is theoretical with no documented incidents in the source text.
Plain-English summary
Spectrum Medical Inc is recalling the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (model CP22V-VT). This device is a non-roller type blood pump used during cardiopulmonary bypass procedures to circulate blood during cardiac surgery.
The recall was issued due to the potential for fluid leakage from the pump. This leakage could occur during the device priming procedure or during clinical use. The affected units correspond to specific lot numbers: F000961, G001207, G001256, and G001511.
Approximately 1,487 units have been distributed nationwide to healthcare facilities across the United States. The recalled devices have been distributed to hospitals and surgical centers in 28 states and the District of Columbia.
Healthcare facilities in possession of affected units should contact Spectrum Medical Inc immediately for instructions. The manufacturer has classified this as a Class II recall. No patient action is necessary, as the device is used only by trained medical personnel in surgical settings.
The recalled product
- 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
- Manufacturer
- Spectrum Medical Inc
- Hazard
- fluid-leakage
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Code: Model No CP22V-VT
- UDI-DI 08051160300624
- Lot Numbers F000961
- G001207
- G001256
- G001511
Distribution
Distributed nationwide across the United States.
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