Z-1327-2025Class II

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

Name: Z-1327-2025 Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood...
Creator: Spectrum Medical Inc
Published: 2025-01-16
License: https://open.fda.gov/license/

Spectrum Medical Inc / initiated 2025-01-16 / Open, Classified / root cause: manufacturing process

FDA source

Spectrum Medical Inc began a recall of Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type... on 2025-01-16. FDA classified it as Class II and gives the reason as "Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1327-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-16
Posted: 2025-03-13
Recalling firm: Spectrum Medical Inc
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
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 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, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.
Product codes and lots: Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1327-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1327-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-13

Product code KFM

K201320Class IIQuantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorQura S.R.L / cleared 2021-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)