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U.S. Department of Health and Human Services

Class 3 Device Recall OasisOne Action Stent Introduction System with ST2 Soehendra Tannenbaum Biliary Stent

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  Class 3 Device Recall OasisOne Action Stent Introduction System with ST2 Soehendra Tannenbaum Biliary Stent see related information
Date Initiated by Firm December 22, 2003
Date Posted January 14, 2004
Recall Status1 Terminated 3 on March 23, 2004
Recall Number Z-0347-04
Recall Event ID 28011
510(K)Number K851962  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable ¿ Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Code Information Reorder number: OATS-11.5-5, Lot number: 1637695, 1651258, 1711817, 1713997, W1730838, W1752589, W1817595; Reorder number: OATS-11.5-7, Lot number: 1637696, 1651259, 1711818, 1711819, W1730839, W1738240; Reorder number: OATS-11.5-9, Lot number: 1637697, 1651260, 1702218, 1711820, 1711821, W1738241; Reorder number: OATS-11.5-12, Lot number: 1637694, 1651257, 1683866, W1730837, W1738238, W1752587; Reorder number: OATS-11.5-15 Lot number: 1692178, 1692179, 1711816, W1738239, W1752588
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		 Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
FDA Determined
Cause 2		 Other
Action Consignee was notified by letter sent via fax on 12/19/2003.
Quantity in Commerce 198 units
Distribution Product was shipped to one distributor in Japan.
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = WILSON-COOK MEDICAL, INC.
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