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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmon Pancreatic Stent

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  Class 3 Device Recall Zimmon Pancreatic Stent see related information
Date Initiated by Firm July 25, 2003
Date Posted October 31, 2003
Recall Status1 Terminated 3 on December 04, 2003
Recall Number Z-0080-04
Recall Event ID 27462
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Code Information Reorder #ZPSOF-7-4-RB, Lot #1615857, 1600284, 1600285.
Recalling Firm/
Wilson-Cook Medical Inc
4900 Bethania Station Rd
& 5951 Grassy Creek Blvd.
Winston-Salem NC 27105
For Additional Information Contact Jessica Hughes
Manufacturer Reason
for Recall
The label is missing the Rx Only symbol.
FDA Determined
Cause 2
Action The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.
Quantity in Commerce 3 units
Distribution Product was distributed to one account in IL.
Total Product Life Cycle TPLC Device Report

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.