BEUDAMED
    FDA Enforcement Class II Terminated

    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.

    Recall: Z-1803-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1803-2018
    Event ID
    79896
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 23, 2018
    Initiation Date
    April 16, 2018
    Classification Date
    May 11, 2018
    Termination Date
    March 2, 2021
    Address
    1625 W 3rd St Bldg 1, Tempe, AZ, 85281-2438, United States

    Description

    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.

    Reason

    Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

    Code Info

    UDI: (01)00801741067907(17)191207(10)VTBZ0193, Lot Number: VTBZ0193

    Distribution

    Nationwide Distribution

    Quantity

    130 units