Z-1584-05

Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191...

Name: Z-1584-05 Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191...
Creator: Cook Urological, Inc.
Published: 2005-08-01
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2005-08-01 / Terminated / root cause: labeling and UDI

FDA source

Cook Urological, Inc. began a recall of Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710 on 2005-08-01. The reason FDA records is "Mislabeled as to size". 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-1584-05
Status: Terminated
Initiated: 2005-08-01
Posted: 2005-09-24
Terminated: 2005-10-26
Recalling firm: Cook Incorporated
Product: Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.
Product code: KOE Dilator, Urethral
Reason for recall: Mislabeled as to size.
Root cause tag: labeling and UDI
FDA 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 in commerce: 3
Distribution: California and Florida.
Product codes and lots: Lots 15-U1320351 and 15-U1320349.

Product code KOE

K811833Class IIVnace Fascial Dilator SetVance Products, Inc. / cleared 1981-07-10

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)