Date Initiated by Firm |
January 08, 2002 |
Date Posted |
August 26, 2003 |
Recall Status1 |
Terminated 3 on March 21, 2005 |
Recall Number |
Z-1181-03 |
Recall Event ID |
26966 |
510(K)Number |
K020788
|
Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
Product |
Zilver Expandable Metal Biliary Stent |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Wilson-Cook Medical Inc 4900 Bethania Station Rd & 5951 Grassy Creek Blvd. Winston-Salem NC 27105
|
For Additional Information Contact |
Sharon Miles 336-744-0157
|
Manufacturer Reason for Recall |
The inner catheter of the introducer system may break after stent deployment.
|
FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
57 units |
Distribution |
The product was distributed to hospitals located nationwide and worldwide. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FGE and Original Applicant = WILSON-COOK MEDICAL, INC.
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