FDA-Device2024-09-25Class II
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Boston Scientific Corporation
Hazard
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Sold states
US, Colombia, Philippines, Russia
Affected count
32 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3148-2024Don't want to check this manually?
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