FDA Medical Device Recalls (openFDA)
Cook Urological, Inc.: Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
- Recall number
- Z-1584-05
- Recalling firm
- Cook Urological, Inc.
- Product
- Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
- Status
- Terminated
- Initiated
- 2005-08-01
- Posted
- 2005-09-24
- Terminated
- 2005-10-26
- Reason
- Mislabeled as to size.
- Root cause
- Other
- Action
- The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit.
- Quantity
- 3
- Distribution
- California and Florida.
- Lot, serial or model codes
- Lots 15-U1320351 and 15-U1320349.
- 510(k) numbers
- ["K811833"]
- PMA numbers
- not on file
- Product code
- KOE
- Firm FEI
- 1825146
- Firm city
- Spencer
- 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