Events

Retiro De Equipo (Recall) de Device Recall Penner

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 Penner Mfg 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
    70151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1306-2015
  • Fecha de inicio del evento
    2015-01-30
  • Fecha de publicación del evento
    2015-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132324
  • 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
    Cover, barrier, protective - Product Code MMP
  • Causa
    If the patient sits on either wing, not squarely on the center section of the stretcher lift, tipping and injury to the operator or patient could result. the device manual was updated with an additional warning statement.
  • Acción
    Beginning on 1/30/2015, the recalling firm sent letters via certified mail to their customers informing them of the change to the stretcher manual along with a revised manual which incorporated those changes. For questions regarding this recall call 402-694-5003.

Device

Device Recall Penner
  • Modelo / Serial
    Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311, 04040581312, 04040581313, 04040581314, 04040586101, 04050810401, 04050810402, 04050810403, 04050810404, 04050810406, 04050810408, 04050810410, 04061028101, 04061028102, 04061028103, 04061028104, 04061028105, 04081009901, 04091187201, 04111563801, 04111568501, 05071272201, 05071272202, 05071272203, 05071272204, 05071272205, 05081019501, 05091197901, 05091197902, 05091201301, 05111513201, 05111576501, 05121762001, 06050840801, 06050840802, 06050840803, 06050840804, 06050840805, 06050840806, 06081037501, 06081039402, 06081039403, 06101394201, 07071320201, 07071320202, 07071328501, 07071328502, 07071328503, 07091223901, 07091223902, 07101410901, 07101415901, 08040660501, 08040660502, 08061090801, 08061090802, 08061090803, 08061090804, 08101430502, 08101439601, 09081073301, 09081074401, 09081076501, 09101453401, 09101457101, 09111641101, 09111641301, 10061121201, 10061121202, 10061121203, 10061121204, 10071396601, 10071396602, 10071396603, 10071396604, 10101463201, 10101464701, 10111652001, 11040710501, 11040710502, 11040710503, 11040710504, 11040710505, 11040710506, 11040710507, 11040710508, 11040710601, 11040710602, 11040710603, 11040710604, 11040710605, 11040710606, 11040710607, 11040710608, 11081101401, 11081105901, 11081113501, 11091285601, 11091285602, 11101475201, 11101476201, 11101476401, 11101477901, 11101478101, 12101495201, 12111677201, 12111686301, 12111686302, 12111688401, 03121734201S, 04040581301A
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Descripción del producto
    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 || The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.
  • Manufacturer
    Penner Mfg Inc

Manufacturer

Penner Mfg Inc
  • Dirección del fabricante
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA