CLASS II ONGOING Device recall · Reported 19 Mar 2025 · FDA Enforcement Report

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type recalled

Spectrum Medical is recalling Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, distributed nationwide in the US. The recall was initiated on 16 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

Quantity recalled1487 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1327-2025
FDA event ID: 96240
Recalling firm: Spectrum Medical, Fort Mill, SC
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jan 2025
FDA classified: 13 Mar 2025
Reported: 19 Mar 2025
Type: Voluntary: Firm initiated
Reason category: Packaging Defects
Device type: Medical Software

Timeline

16 Jan 2025	Recall initiated by company
13 Mar 2025	Classified by FDA	+56 days
19 Mar 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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 Carolina, Tennessee, Texas, Utah, and Washington.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Missouri Mississippi New York Ohio

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Spectrum Medical

All 5

Reported	Class	Recall	Company	Reason	Where
7 May 2025Device	CLASS II	Quantum Informatics - Vision / Live Vue Monitor recalled	Spectrum Medical	Device Malfunction	38 states
7 May 2025Device	CLASS II	Quantum Informatics - Viper Monitor, Physiological, Patient recalled	Spectrum Medical	Device Malfunction	38 states
30 Oct 2024Device	CLASS II	Quantum Perfusion Systems for CPB recalled by Spectrum Medical	Spectrum Medical	Other	Nationwide
4 Sep 2019Device	CLASS I	Quantum Pump Console recalled by Spectrum Medical	Spectrum Medical	Other	4 states

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