Recalls / —

—#28034

Product

Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.

Affected lot / code info

All units distributed from February 24, 2003 through June 26, 2003.

Why it was recalled

Vial contains less product than is declared on the label.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Cook, Inc.

Address

750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern

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

Timeline

Recall initiated

2003-07-01

Posted by FDA

2003-07-29

Terminated

2003-11-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #28034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.