Cook Medical Incorporated recalls Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-1
Recalled Product
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 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
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