Events

Rappel de Device Recall Purely Yours Breast Pumps

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par AMEDA, INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78237
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0616-2018
  • Date de mise en oeuvre de l'événement
    2017-07-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158977
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, breast, powered - Product Code HGX
  • Cause
    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
  • Modèle / numéro de série
    Lot 7E058 and Lot 7E308
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
  • Description du dispositif
    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.
  • Adresse du fabricant
    AMEDA, INC., 485 E Half Day Rd Ste 320, Buffalo Grove IL 60089-8806
  • Société-mère du fabricant (2017)
    Ameda Inc.
  • Source
    USFDA