BEUDAMED
    FDA Enforcement Class III Ongoing

    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.

    Recall: Z-0616-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0616-2018
    Event ID
    78237
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMEDA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 21, 2018
    Initiation Date
    July 10, 2017
    Classification Date
    February 15, 2018
    Address
    485 E Half Day Rd Ste 320, Buffalo Grove, IL, 60089-8806, United States

    Description

    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.

    Reason

    Two specific lots was incorrectly manufactured containing a UK power adapter.

    Code Info

    Lot 7E058 and Lot 7E308

    Distribution

    Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.

    Quantity

    3,327 units total