BEUDAMED
    FDA Enforcement Class II Terminated

    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for 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-0960-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0960-2019
    Event ID
    82015
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2019
    Initiation Date
    July 3, 2018
    Classification Date
    February 26, 2019
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630, United States

    Description

    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for 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

    Incorrect expiration being entered for one lot.

    Code Info

    Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593

    Distribution

    US Nationwide Distribution - NC and NY

    Quantity

    26 units