Events

Retiro De Equipo (Recall) de Device Recall CaviCide

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 Metrex Research, LLC..

¿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
    62864
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2267-2012
  • Fecha de inicio del evento
    2012-02-06
  • Fecha de publicación del evento
    2012-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111894
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • Causa
    Metrex research is recalling cavicide containing the spring fresh fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.
  • Acción
    Metrex sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Mandatory Recall Response Form was attached for customers to complete and return via fax to 734-947-6725. Contact Customer Care Center at (800) 841-1428 for questions regarding this recall.

Device

Device Recall CaviCide
  • Modelo / Serial
    CaviCide Lot # 10-1301, 10-2301, 10-2302, 10-2328, 10-2328A, 10-2328B, 10-2331, 10-2333, 10-1334, 10-2334, 10-1335, 10-2335, 10-1342A, 10-1343, 10-2345.  EnviroCide Lot # 10-2331.  Backscratchers Cavicide lot # 10-1342.  MaxiSpray Plus lot # 10-2328A and 10-1343.  pdCARE Surface Disinfectant lot # 10-2331 and 10-2345.  Z3 Surface Disinfectant lot # 10-2328.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
  • Descripción del producto
    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. || Alternate brands: || EnviroCide, part number: 13-3325. || Private labeled products of Cavicide: || Backscratchers Cavicide, part number: 13-4800. || MaxiSpray Plus, part numbers: 13-7400 and 13-7405. || pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. || Z3 Surface Disinfectant, part number: 13-7900. || CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas.
  • Manufacturer
    Metrex Research, LLC.

Manufacturer

Metrex Research, LLC.
  • Dirección del fabricante
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA