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Boston Scientific Corporation recalls Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Recalled March 20, 2019 · FDA recall Z-1013-2019 · Boston Scientific
Hazard
The sterile barrier may contain packaging seal defects. · FDA Class II
Units
18 units
Sold at
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.
Description
The sterile barrier may contain packaging seal defects.
Product
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →