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Terminated

Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.

FDA Recall Z-1058-03 · Posted 2003-07-29

Recalling FirmCook, Inc.
Recall StatusTerminated
Date Initiated2003-07-01
Date Terminated2003-11-13
Product Quantity864

Reason for Recall

Vial contains less product than is declared on the label.

Firm Action

A recall letter dated July 1, 2003 was sent to all customers receiving product during the recall time period asking for a return of the product.

Root Cause

Other

Distribution Pattern

United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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