Boston Scientific Corporation recalls Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pi

Recalled September 25, 2024 · FDA recall Z-3148-2024 · Boston Scientific

Hazard

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. · FDA Class II

Units

32 units

Sold at

US, Colombia, Philippines, Russia

Description

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Product

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →