Date Initiated by Firm |
April 21, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on August 17, 2004 |
Recall Number |
Z-0908-04 |
Recall Event ID |
28905 |
510(K)Number |
K851962
|
Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
Product |
Biliary Stent Introducer Set |
Code Information |
Reorder (catalog) number SIS-10, Lot number W1733880 |
Recalling Firm/ Manufacturer |
Wilson-Cook Medical Inc 5951 Grassy Creek Blvd Winston Salem NC 27105-1206
|
For Additional Information Contact |
Jessica Hughes 336-744-0157
|
Manufacturer Reason for Recall |
The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor . |
Quantity in Commerce |
23 pieces |
Distribution |
MO, NY, PA, Australia, Israel and England |
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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