BEUDAMED
    FDA Enforcement Class II Terminated

    Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Recall: Z-2525-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2525-2015
    Event ID
    71893
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 6, 2015
    Classification Date
    September 1, 2015
    Termination Date
    June 29, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Reason

    Sterility may be compromised

    Code Info

    Lot Numbers: P15035 P15036 P15037 P15041 P15042 P15046 P15047 P15048 P15049 P15056 P15057 P15058 P15059 P15063 P15064 P15069 P15070 P15071 P15078 P15079 P15080 P15081 P15091

    Distribution

    US Nationwide Distribution

    Quantity

    207,876