Z-0391-06

Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm...

Name: Z-0391-06 Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm...
Creator: Cook, Inc.
Published: 2005-10-24
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2005-10-24 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0... on 2005-10-24. The reason FDA records is "The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct". 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-0391-06
Status: Terminated
Initiated: 2005-10-24
Posted: 2006-01-13
Terminated: 2006-04-10
Recalling firm: Cook Incorporated
Product: Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.
Quantity in commerce: 9
Distribution: Connecticut, Michigan, Minnesota, Montana, Nevada, Pennsylvania, Utah, Wisconsin and Canada.
Product codes and lots: Lot 1544171.

Product code FGE

K051124Class IIZilver 635 Biliary StentCook, Inc. / cleared 2005-07-12

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)