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Class 2 Device Recall Boston Scientific Stonetome Stone Removal Device |
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Date Initiated by Firm |
January 08, 2009 |
Date Posted |
March 11, 2009 |
Recall Status1 |
Terminated 3 on October 22, 2009 |
Recall Number |
Z-1010-2009 |
Recall Event ID |
50861 |
510(K)Number |
K946358
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Product Classification |
Dislodger, stone, biliary - Product Code LQR
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Product |
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511.
The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon. |
Code Information |
Lot Numbers: 12012906, 12013569 and 12039341. |
Recalling Firm/ Manufacturer |
Boston Scientific Corp 780 Brookside Dr Spencer IN 47460-1080
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For Additional Information Contact |
866-868-4004
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Manufacturer Reason for Recall |
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
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FDA Determined Cause 2 |
Packaging |
Action |
Consignees were notified via letter dated January 8, 2009 to discontinue use of the affected product and to return it to Boston Scientific. Customers were instructed to complete and fax the Reply Verification Tracking Form to Boston Scientific at 508-683-5578. Direct questions about this recall to your local Sales Representative. |
Quantity in Commerce |
294 of all products. |
Distribution |
Nationwide. |
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 = LQR and Original Applicant = BOSTON SCIENTIFIC CORP.
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