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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96240

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 16, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Spectrum Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1327-2025
Recall number
Z-1327-2025
Initiated
January 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Spectrum Medical Inc
Quantity
1487 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.