ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA Recall Z-0089-04 · Posted 2003-11-06
Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2002-08-21
Date Terminated2003-12-11
Product Quantity155 units
Reason for Recall
Complaints were reported of difficulty in stent deployment.
Firm Action
Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.
Root Cause
Other
Distribution Pattern
The device was distributed nationwide, Ireland and Jordan.
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.