Events

Rappel de Device Recall Beauty Angel

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 JK Products & Services, Inc.

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
    61855
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2183-2012
  • Date de mise en oeuvre de l'événement
    2012-05-07
  • Date de publication de l'événement
    2012-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109244
  • 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
    Beauty Angel - Product Code 000
  • Cause
    The beauty angel was marketed without a 510k.
  • Action
    JK Products sent a Mandatory Field Correction Notice - Immediate Action Required letter dated February 10, 2012, to all affected customers. The letter identified the product the problem, and the action to be taken by the customer. The firm instructed customers that they would be replacing the operating instructions for the affected product with new ones that meet the requirements defined by the regulatory authorities. Customers were instructed not to make claims that indicate that using the affected product will result in medical or health benefits, or that directly or indirectly imply that the affected product is intended to cure, treat, diagnose or pevent an illness, or disease. Customers were asked to complete the new owner information request on the return post care enclosed and return to the firm. If product was further distributed those accounts should be contacted immediately and should be advised of this Mandatory Field Correction Notice. For questions customers should call 870-935-1130. For questions regarding this recall call 870-268-2702.

Device

Device Recall Beauty Angel
  • Modèle / numéro de série
    All Beauty Angel Models and Serial Numbers Part Numbers 80000904301 and 8001110201.
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada
  • Description du dispositif
    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging || For human use.
  • Manufacturer
    JK Products & Services, Inc

Manufacturer

JK Products & Services, Inc
  • Adresse du fabricant
    JK Products & Services, Inc, 1 Walter Kratz Dr, Jonesboro AR 72401-0609
  • Source
    USFDA