BEUDAMED
    FDA Enforcement Class II Terminated

    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

    Recall: Z-1194-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1194-2018
    Event ID
    79474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 4, 2018
    Initiation Date
    December 15, 2017
    Classification Date
    March 26, 2018
    Termination Date
    July 18, 2019
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

    Reason

    Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

    Code Info

    Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

    Distribution

    Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

    Quantity

    305