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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors

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 Class 2 Device Recall Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensorssee related information
Date Initiated by FirmJanuary 16, 2025
Date PostedMarch 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1327-2025
Recall Event ID 96240
510(K)NumberK201320 
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
ProductBrand 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
Code Information Lot Code: Model No CP22V-VT; UDI-DI 08051160300624; Lot Numbers F000961, G001207, G001256, G001511
Recalling Firm/
Manufacturer		 Spectrum Medical Inc
481 Munn Rd Ste 250
Fort Mill SC 29715-8408
For Additional Information ContactCameron Schmitt
803-802-1441
Manufacturer Reason
for Recall		Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
FDA Determined
Cause 2		Process control
ActionOn 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 Commerce1487 unit
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KFM
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