Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
FDA Recall Z-2105-2008 · Posted 2008-09-11
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Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-04-02
Date Terminated2008-09-11
Product Quantity80
Reason for Recall
Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.
Firm Action
An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form.
Root Cause
Packaging process control
Distribution Pattern
Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.
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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