BEUDAMED
    FDA Enforcement Class II Terminated

    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

    Recall: Z-1326-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1326-2015
    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 One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

    Reason

    Devices were not sterilized

    Code Info

    SKU 17161; Lot 5A22

    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

    1763