Events

Rappel de Device Recall CaviCide

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Metrex Research, LLC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    62864
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2267-2012
  • Date de mise en oeuvre de l'événement
    2012-02-06
  • Date de publication de l'événement
    2012-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111894
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Disinfectant, medical devices - Product Code LRJ
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, and YE.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA