Reported Sep 23, 2020 · Terminated
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- WallFlexTM Biliary RX Fully Covered
- Stent System RMV (10mmx60mm Stent) UPNM00570370 -
- Product Usageis indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery
- Lot codes and dates
- Lot code25607019 Exp
- Date
June 17th2022
- GIN08714729953180
- Amount recalled
- 40 units
Where it was sold
- Nationwide
Why it was recalled
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
This product could cause temporary or reversible health problems — stop using it.
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