BEUDAMED
    FDA Enforcement Class II Terminated

    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

    Recall: Z-1327-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1327-2015
    Event ID
    70599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameda, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    February 12, 2015
    Classification Date
    March 26, 2015
    Termination Date
    July 21, 2017
    Address
    485 E Half Day Rd Ste 320, Buffalo Grove, IL, 60089-8806, United States

    Description

    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.

    Reason

    Devices were not sterilized

    Code Info

    SKU 17115; Lot 5B01

    Distribution

    Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.

    Quantity

    12 collection systems