BEUDAMED
    FDA Enforcement Class II Ongoing

    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

    Recall: Z-0731-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0731-2025
    Event ID
    95707
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    November 6, 2024
    Classification Date
    December 20, 2024
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630, United States

    Description

    20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

    Reason

    Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

    Code Info

    UDI-DI: 08717648013614, Lots: 60538750, 60538751, 60539113, 60545329

    Distribution

    US: IA, MD, DC, IN, CA, NV, TX, CT, GA, MS, NY, OH, FL, NC, MI, KY, PA, VA, IL, OK, TN, UT, WA, WI, MT, OR, LA, HI, NE, AR, MO, MA, KS, ID, AL, AZ, PR, CO, SC. OUS: IN, KR, SG, TH, VN, AR, BR, CA, CO, PA, UY, BE, CZ, DE, ES, FR, GB, IT, PT, RE, SE, SK, TM, JP.

    Quantity

    3,673