Events

Rappel de Device Recall Instructions for Use for Symphony Double Pumping Kit

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 Medela 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
    54995
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1442-2010
  • Date de mise en oeuvre de l'événement
    2010-03-15
  • Date de publication de l'événement
    2010-04-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89645
  • 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
    The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
  • Action
    An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.

Device

Device Recall Instructions for Use for Symphony Double Pumping Kit
  • Modèle / numéro de série
    item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: || a) Model 67023, Harmony to Symphony Conversion Kit; || b) Model 67091, Lactina to Symphony Conversion Retail Kit; || c) Model 67099, Symphony Retail Kit; || d) Model 67099-06, Symphony Retail Kit - case of 6 kits; || e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
  • Manufacturer
    Medela Inc

Manufacturer

Medela Inc
  • Adresse du fabricant
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Société-mère du fabricant (2017)
    Olle Larsson Holding Ag
  • Source
    USFDA