Events

Retiro De Equipo (Recall) de Device Recall MRVLS 4W GXL: W1/R RBLS

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 Elcam Medical, 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
    71880
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2749-2015
  • Fecha de inicio del evento
    2015-07-19
  • Fecha de publicación del evento
    2015-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139296
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Causa
    Punctured blister packages were detected during the packaging process at the manufacturing site. potential for device contamination.
  • Acción
    Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.

Device

Device Recall MRVLS 4W GXL: W1/R RBLS
  • Modelo / Serial
    Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401  Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901  Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801  Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501  Elcam Part Number: 477101; lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601  Elcam Part Number: 477102; lot numbers: 1370261201, 1570323201  Elcam Part Number: 477901; lot number: 1370255601  Elcam Part Number: 477904; lot number: 1470300101  Elcam Part Number: 478003; lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201  Elcam Part Number: 478004; lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801  Elcam Part Number: 478701; lot numbers: 1270244901, 1370261301, 1370271901  Elcam Part Number: 478704; lot numbers: 1470296201, 1470299101, 470307201, 1470312901
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Texas, New Mexico and Pennsylvania
  • Descripción del producto
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
  • Manufacturer
    Elcam Medical, Inc.

Manufacturer

Elcam Medical, Inc.
  • Dirección del fabricante
    Elcam Medical, Inc., 2 University Plz Ste 620, Hackensack NJ 07601-6224
  • Empresa matriz del fabricante (2017)
    Elcam Medical, Inc.
  • Source
    USFDA