BEUDAMED
    FDA Recall Open, Classified

    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

    Recall: Z-2253-2023 · Initiated June 22, 2023

    Recall

    Recall Number
    Z-2253-2023
    Event Number
    92648
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    FFL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 22, 2023
    Posted
    July 28, 2023
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    Description

    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

    Reason

    Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

    Action

    Cook Medical issued an URGENT: MEDICAL DEVICE REMOVAL notice to their consignees on 07/14/2023 by email or priority mail. The notice explained the issue, the risk, and requested the consignee cease use and return the affected product.

    Distribution

    Worldwide distribution.

    Quantity

    402 units