Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M0053...
FDA Recall #Z-1012-2019 — Class II — December 26, 2018
Product Description
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Reason for Recall
The sterile barrier may contain packaging seal defects.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
75 units
Distribution
The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Code Information
Lot 22960202
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated