Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.

FDA device recall Z-1057-03 · posted 2003-07-29 · Terminated

Recall details

Recalling firm

Cook, Inc.

Reason for recall

Vial contains less product than is declared on the label.

Action taken

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

Status

Terminated

Quantity affected

2250

Distribution

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

Date initiated

2003-07-01

Date posted

2003-07-29

Date terminated

2003-11-13

Location

Bloomington, IN