Events

Rappel de Device Recall Pump in Style Advanced Breast Pump

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
    57597
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1224-2011
  • Date de mise en oeuvre de l'événement
    2011-01-10
  • Date de publication de l'événement
    2011-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96744
  • 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 performance of the pumps may be compromised due to the potentiometer used on the circuit board. affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
  • Action
    This firm, Medela, sent an "Important Device Recall" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns.com to expedite shipment of a replacement unit. Questions about the recall process were directed to Medela Customer Service at 1-800-435-8316 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelareturns.com on January 11, 2011.

Device

Device Recall Pump in Style Advanced Breast Pump
  • Modèle / numéro de série
    manufacture dates 02/10/10 through 03/03/10
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, including Puerto Rico
  • Description du dispositif
    Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: || a) article 57027 - Kit PNSA Shoulder Bag; || b) article 57027T - Kit PNSA Shoulder Bag Tagged; || c) article 57036T - Kit PNSA The Metro Bag Tagged; || d) article 57043 - PNSA without kit; || e) article 57062 - Kit PNSA Backpack; || f) article 57062-03 - Kit PNSA Backpack CA/3; || g) article 57062T - Kit PNSA Backpack Tagged; || h) 57102 - Motor Replacement PNSA Backpack 57062; || i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 || Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.
  • 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