BEUDAMED
    FDA Enforcement Class II Ongoing

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

    Recall: Z-0457-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0457-2024
    Event ID
    93326
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2023
    Initiation Date
    November 3, 2023
    Classification Date
    December 1, 2023
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203, United States

    Description

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

    Reason

    Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

    Code Info

    UDI/DI 00827002226579 (each), 10827002226576 (case), Lot Numbers: W4746514, W4746515, W4753822, W4756371, W4756904, W4720845, W4721268, W4722642, W4722645, W4722982, W4723311, W4724690, W4738719, W4739842, W4740111, W4746917, W4747437, W4747835, W4748251, W4748466, W4748945, W4748964, W4749235, W4749509, W4750012, W4750870, W4750909, W4751106, W4751509, W4752279, W4752282, W4752904, W4752906, W4752907, W4753363, W4753364, W4753366, W4754261, W4754262, W4754850, W4754851, W4755407, W4756476, W4758648, W4758928, W4759512, W4759979, W4760465, W4760865, W4761224, W4762151

    Distribution

    US

    Quantity

    731 devices