medical Class II Updated 2018-11-07

Cook Medical Incorporated recalls Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-12

Recalled Product

Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

Hazard / Issue

The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GPN: G31352
View official government recall

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