Events

Rappel de Device Recall Ameda

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
    70599
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1327-2015
  • Date de mise en oeuvre de l'événement
    2015-02-12
  • Date de publication de l'événement
    2015-03-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134107
  • 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, non-powered - Product Code HGY
  • Cause
    Devices were not sterilized.
  • Action
    Ameda sent an URGENT: MEDICAL DEVICE RECALL letter dated February 12, 2015 to all affected customers. The letter included instructions for distributors to: 1) quarantine the recalled products; 2) complete and return the enclosed Recall Response Forms within 3 days of receiving the letter; 3) upon receipt of the completed Recall Response Form, an Ameda representative would contact the distributor to make arrangements for the return of the recalled products; 4) Ameda will use the information provided in the returned Recall Response Form to contact the distributor's customers of record to arrange for the return of recalled product that was already shipped to the customers of record; and, 5) replacement product will be shipped to both distributors and their customers of record upon receipt of the completed Recall Response Form. Questions about this recall will be answered by Ameda personnel who can be reached at 847-964-2645.

Device

Device Recall Ameda
  • Modèle / numéro de série
    SKU 17115; Lot 5B01
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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.
  • 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