BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

    Recall: Z-1477-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1477-2020
    Event ID
    84680
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    January 8, 2020
    Classification Date
    March 12, 2020
    Termination Date
    January 13, 2023
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

    Reason

    Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.

    Code Info

    Lot 82155955, Use by date 2021-06-30

    Distribution

    US and UK

    Quantity

    89 units