Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
FDA Recall Z-0113-2009 · Posted 2008-10-14
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Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-09-11
Date Terminated2009-04-01
Product Quantity12
Reason for Recall
A section of the introduction system may detach after the stent has deployed.
Firm Action
The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance.
Root Cause
Process control
Distribution Pattern
USA: IL and OUS: China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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