Events

Recall of Device Recall Purely Yours Breast Pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMEDA, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78237
  • Event Risk Class
    Class 3
  • Event Number
    Z-0616-2018
  • Event Initiated Date
    2017-07-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158977
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, breast, powered - Product Code HGX
  • Reason
    Two specific lots was incorrectly manufactured containing a uk power adapter.
  • Action
    Customers were notified initially by phone call on 07/10/2017 and "Device Recall" letters were mailed, via FedEx overnight delivery on 07/10/2017. Instructions included to place any affected product in quarantine, complete and return Correction Response Form, return any product in inventory, notify customers if further distributed, and that replacement product will be provided upon return of their customer's completed Correction Response Form. Any questions can be directed to Ameda at 877-992-6332, press #1. The recall was expanded on 08/18/2017 and customers were notified by letter, via FedEx, on 08/18/2017 through 08/22/2017. Instructions are the same as the initial notification above.

Device

Device Recall Purely Yours Breast Pumps
  • Model / Serial
    Lot 7E058 and Lot 7E308
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
  • Product 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.
  • Manufacturer
    AMEDA, INC.

Manufacturer

AMEDA, INC.
  • Manufacturer Address
    AMEDA, INC., 485 E Half Day Rd Ste 320, Buffalo Grove IL 60089-8806
  • Manufacturer Parent Company (2017)
    Ameda Inc.
  • Source
    USFDA