Cook, Inc. Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 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 # ZIB6-80-7.0-40. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 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 # ZIB6-80-7.0-40.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lot 1546123.
Products Sold
Lot 1546123.
Cook, Inc. is recalling Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter due to The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, MI, MN, MT, NV, PA, UT, WI
Page updated: Jan 10, 2026