Spectrum Medical recalls Quantum Perfusion CP22 blood pumps with potential fluid leakage during priming or clinical procedures. Affected units have specific model numbers and lot codes.
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Spectrum Medical is recalling Quantum Perfusion CP22 blood pumps that may leak fluid during priming or clinical procedures. This could cause contamination or infection risks if fluid contacts the patient.
Fluid leakage during priming or clinical procedures could contaminate the patient or surgical site. This might lead to infection or other complications if the leaked fluid contacts the patient.
Healthcare professionals using the CP22 blood pump for cardiopulmonary bypass procedures are most at risk. Patients receiving the pump during surgery could be exposed to potential fluid leaks.
Check for model number CP22V-VT on the pump. Affected units have lot numbers F000961, G001207, G001256, or G001511. The pump is used for cardiopulmonary bypass procedures.
Look for model number CP22V-VT on the pump to confirm if it's affected.
Contact Spectrum Medical for specific instructions on how to handle the pump if it's affected.
The affected model number is CP22V-VT.
Lot numbers F000961, G001207, G001256, and G001511 are affected.
The recall record does not mention a specific fix or remedy for the fluid leakage issue.
We’ve drafted a message you can send Quantum Perfusion to request your refund or repair — edit it as you like.
Subject: Recall Z-1327-2025 — Quantum Perfusion Quantum Perfusion Hello, I own a Quantum Perfusion that is covered by recall Z-1327-2025 from Quantum Perfusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.