BEUDAMED
    FDA Recall Terminated

    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

    Recall: Z-2825-2015 · Initiated August 27, 2015

    Recall

    Recall Number
    Z-2825-2015
    Event Number
    72086
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 27, 2015
    Posted
    September 30, 2015
    Terminated
    June 18, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes

    Reason

    Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.

    Action

    An urgent recall notification letter, dated August 27, 2015, was sent to direct consignees to inform them of the issue and provided instructions for removing the syringes from the kit and returning product along with the response form.

    Distribution

    Nationwide and internationally.

    Quantity

    73714