| Class 2 Device Recall Ultraflex Precision Colonic Stent System | |
Date Initiated by Firm | July 15, 2010 |
Date Posted | August 31, 2010 |
Recall Status1 |
Terminated 3 on October 14, 2011 |
Recall Number | Z-2331-2010 |
Recall Event ID |
56331 |
510(K)Number | K060323 |
Product Classification |
Stent, colonic, metalic, expandable - Product Code MQR
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Product | Boston Scientific Ultraflex Precision Colonic Stent System
Material/UPN/Catalog Number: M00557360 |
Code Information |
Lot/Batch Number: 13432574 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
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For Additional Information Contact | 508-683-8000 |
Manufacturer Reason for Recall | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
FDA Determined Cause 2 | Process control |
Action | Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations.
Boston Scientific can be contacted at 1-508-683-4427. |
Quantity in Commerce | 8 units |
Distribution | Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden |
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.
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510(K) Database | 510(K)s with Product Code = MQR
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