FDA-Device2019-03-20Class II
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Hazard
The sterile barrier may contain packaging seal defects.
Sold states
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.
Affected count
18 units
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2019More Boston Scientific Corporation recalls
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