Class II

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

Boston Scientific Corporation · July 18, 2024

Reason for Recall

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

Distribution

US, Colombia, Philippines, Russia

Quantity Affected

32 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3148-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Boston Scientific Corporation Medical Device Recall: Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail | SafeCheck