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.
This recall has been terminated (originally issued October 14, 2008).
- Company
- Cook Endoscopy
- Recall Initiated
- September 11, 2008
- Posted
- October 14, 2008
- Terminated
- April 1, 2009
- Recall Number
- Z-0113-2009
- Quantity
- 12
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
A section of the introduction system may detach after the stent has deployed.
Distribution
USA: IL and OUS: China
Lot / Code Info
Lot number W2528796
Root Cause
Process control
Action Taken
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.
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