FDA-Device2019-03-20Class II
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Boston Scientific Corporation
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
75 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) x10cm, Material Number M00539220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2019Don't want to check this manually?
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