Events

Rappel de Device Recall Harris Medical UV Lamp

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 Harris Medical Resources.

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
    55724
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1808-2010
  • Date de mise en oeuvre de l'événement
    2010-05-13
  • Date de publication de l'événement
    2010-06-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91667
  • 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
    Medical ultra-violet (UV) Lamp - Product Code MXG
  • Cause
    The harris uv lamp was promoted for sub-lingual treatment of hiv/aids; hepatitis b; hepatitis c; malaria, typhoid, amoeba infections and other blood diseases. the product was marketed without a 510(k), or an approved application for premarket approval (pma) or an approved application for an investigational device exemption (ide). questions are directed to the firm at 773-583-7500.
  • Action
    Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.

Device

Device Recall Harris Medical UV Lamp
  • Modèle / numéro de série
    All models, serial numbers and lot numbers are subject to this recall.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru
  • Description du dispositif
    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"
  • Manufacturer
    Harris Medical Resources

Manufacturer

Harris Medical Resources
  • Adresse du fabricant
    Harris Medical Resources, 3535 W Irving Park Rd, Chicago IL 60618-3219
  • Source
    USFDA