Zilver Expandable Metal Biliary Stent
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- January 8, 2002
- Posted
- August 26, 2003
- Terminated
- March 21, 2005
- Recall Number
- Z-1181-03
- Quantity
- 57 units
- Firm Location
- Winston-Salem, NC
Reason for Recall
The inner catheter of the introducer system may break after stent deployment.
Distribution
The product was distributed to hospitals located nationwide and worldwide.
Lot / Code Info
Reorder #ZILBS-6-6 ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4, ZILBS-6-8
Root Cause
Other
Action Taken
Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.
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