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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 Stentsee related information
Date Initiated by FirmDecember 22, 2003
Date PostedJanuary 14, 2004
Recall Status1 Terminated 3 on March 23, 2004
Recall NumberZ-0347-04
Recall Event ID 28011
510(K)NumberK851962 
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
ProductOasis-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
FEI Number 1037905
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information ContactJessica 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
ActionConsignee was notified by letter sent via fax on 12/19/2003.
Quantity in Commerce198 units
DistributionProduct was shipped to one distributor in Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FGE
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