FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
- Recall number
- Z-1059-03
- Recalling firm
- Cook, Inc.
- Product
- Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
- Status
- Terminated
- Initiated
- 2003-07-01
- Posted
- 2003-07-29
- Terminated
- 2003-11-13
- Reason
- Vial contains less product than is declared on the label.
- 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
- 216
- Distribution
- United States, Australia, Brazil, Canada, Denmark, Hong Kong, India, Israel, Japan and Taiwan.
- Lot, serial or model codes
- All units distributed from February 24, 2003 through June 26, 2003.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28