Reported Mar 19, 2025 · Ongoing

Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood,…

Spectrum Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spectrum Medical Inc · 481 Munn Rd Ste 250 · Fort Mill, SC · 29715-8408

Is this the product you have?

  • Brand NameQuantum Perfusion Centrifugal Blood Pump CP22
  • with Integrated Sensors Product NamePump, Blood, Cardiopulmonary Bypass
  • Non-Roller Type Model/Catalog NumberCP22V-VT
  • Software VersionN/A
Lot codes and dates
  • Lot Code
    • Model No CP22V-VT
    • UDI-DI 08051160300624
    • Lot Numbers F000961
    • G001207
    • G001256
    • G001511
Amount recalled
1487 unit

Where it was sold

Why it was recalled

Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.