Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513. 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.
FDA Recall Z-1011-2009 · Posted 2009-03-11
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeLQR
Date Initiated2009-01-08
Date Terminated2009-10-22
Product Quantity294 of all products.
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.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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