Z-0080-2007

Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent...

Name: Z-0080-2007 Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent...
Creator: Cook, Inc.
Published: 2006-09-21
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2006-09-21 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French... on 2006-09-21. The reason FDA records is "The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)". 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-0080-2007
Status: Terminated
Initiated: 2006-09-21
Posted: 2006-10-28
Terminated: 2007-04-04
Recalling firm: Cook Incorporated
Product: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.
Quantity in commerce: 5
Distribution: Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada
Product codes and lots: Lot 1722922.

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)