Events

Retiro De Equipo (Recall) de Xenon Diagnostic Circuit Kits

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 Continental Medical Labs,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
    55527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1754-2010
  • Fecha de inicio del evento
    2010-04-16
  • Fecha de publicación del evento
    2010-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91038
  • 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
    filter, bacterial, breathing-circuit - Product Code CAH
  • Causa
    Cml, inc. was notified by a-m systems in a letter dated march 31, 2010 that they were recalling a component of their xenon kit (viromax viral and bacterial filter) because the filters may have a leak at the seam where the two halves of the filter are bonded together.
  • Acción
    The firm, A-M Systems, sent two "URGENT: Notification of Product Recall/Correction" letters one dated March 31, 2010 and the other dated April 7, 2010 to customers. The letters described the product, problem and action to be taken by customers. Also enclosed was a list of the affected products that was sold to the consignee. The customer was instructed to cease further distribution or use of any remaining products from the listed lots, immediately notify any customers who received products from the lots, provide A-M Systems with the number of items distributed and still remaining in their inventory, once the number is provided the customer should destroy or discard any remaining product in their possession from these lot numbers. Please feel free to contact Robert Thompson by phone 360-683-8300 x302 or email: rthompson@a-msystems.com with any questions, comments or concerns.

Device

Xenon Diagnostic Circuit Kits
  • Modelo / Serial
    Lot #'s for RAF Medical, Inc.:  1002092, 1001211, 1002011, 1002192, 1003081, 1003231, 1002012, 1003085, 1001263, 1003186,1004051, 1002112, 1003086, 1003082, 1003245, 1003291, 1002081, 1002111, 1001222, 1002193, 1003083, 1003241, 1002013, 1003084, 1003242, 1001181, 1003296,   Lot #'s for Medico-Mart: 10020414, 1002191, 1003088
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: WI
  • Descripción del producto
    Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 || RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). || Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.
  • Manufacturer
    Continental Medical Labs,Inc

Manufacturer

Continental Medical Labs,Inc
  • Dirección del fabricante
    Continental Medical Labs,Inc, 813 Ela Ave / PO Box 306, Waterford WI 53185-0306
  • Empresa matriz del fabricante (2017)
    Continental Medical Labs, Inc
  • Source
    USFDA