Events

Retiro De Equipo (Recall) de AC Adaptor Article 9207010

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medela Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58431
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2386-2011
  • Fecha de inicio del evento
    2011-04-04
  • Fecha de publicación del evento
    2011-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99330
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Breast pump kit - Product Code OHH
  • Causa
    The power adaptor (transformer) used with the pump in style advanced family of breast pumps have power cords that may easily become damaged if not properly handled.
  • Acción
    Medela Inc., sent an " IMPORTANT FIELD ACTION " letter dated April 4, 2011, to all affected customers via The United States Postal Service ( USPS) United Parcel Service ( UPS) and E-mail .The letter identified the product, the problem, and the action to be taken by the customer. It was discovered the power adaptor/transformer used with the Pump in Style Advanced family of breast pumps can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the power cord. Use of the power adaptor with a damaged cord could result in a short in the cord resulting in sparks, smoke, burning and melting of the transformers. If the users have a damaged power adaptor or power adaptor cord, they were requested to discontinue use of the adaptor and visit Medela's website at www.poweradaptorhelp.com to request a replacement adaptor. Questions about the recall process were directed to Medela Customer Service at 1-855-367-0104 or e-mail at poweradaptor@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.medelapoweradaptorhelp.com on April 4, 2011.

Device

AC Adaptor Article 9207010
  • Modelo / Serial
    Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti. CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district.
  • Descripción del producto
    AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. || Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.
  • Manufacturer
    Medela Inc

Manufacturer

Medela Inc
  • Dirección del fabricante
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Empresa matriz del fabricante (2017)
    Olle Larsson Holding Ag
  • Source
    USFDA