BEUDAMED
    FDA Enforcement Class II Ongoing

    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

    Recall: Z-0844-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0844-2020
    Event ID
    84635
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2020
    Initiation Date
    December 12, 2019
    Classification Date
    January 23, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.

    Reason

    The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

    Code Info

    Lot/Batch Number: PMC 23F19H0224

    Distribution

    US distribution to SC

    Quantity

    80 eaches