BEUDAMED
    FDA Recall Open, Classified

    Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

    Recall: Z-3147-2024 · Initiated July 18, 2024

    Recall

    Recall Number
    Z-3147-2024
    Event Number
    95186
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    FFA
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    July 18, 2024
    Posted
    September 13, 2024
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

    Reason

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

    Action

    Boston Scientific issued am Urgent Medical Device Removal notice to it consignees on 07/18/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the return of the devices. Consignees were directed to post the notice in a visible location near the affected products to ensure visibility and to share the notice with all those to whom the device was transferred. Distributors were direct to notify their customers.

    Distribution

    US, Colombia, Philippines, Russia

    Quantity

    89 units