Z-1058-03

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

Name: Z-1058-03 Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number...
Creator: Cook, Inc.
Published: 2003-07-01
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2003-07-01 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500 on 2003-07-01. The reason FDA records is "Vial contains less product than is declared on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1058-03
Status: Terminated
Initiated: 2003-07-01
Posted: 2003-07-29
Terminated: 2003-11-13
Recalling firm: Cook Incorporated
Product: Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.
Reason for recall: Vial contains less product than is declared on the label.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 864
Distribution: United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.
Product codes and lots: All units distributed from February 24, 2003 through June 26, 2003.

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)