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.
This recall has been terminated (originally issued September 11, 2008).
- Company
- Boston Scientific Corp
- Recall Initiated
- April 2, 2008
- Posted
- September 11, 2008
- Terminated
- September 11, 2008
- Recall Number
- Z-2105-2008
- Quantity
- 80
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package.
Distribution
Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain.
Lot / Code Info
Lot 11374425.
Root Cause
Packaging process control
Action Taken
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.
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