Events

Rappel de Device Recall BREG Cold Therapy Combination Units

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 Breg 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
    64177
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0803-2013
  • Date de mise en oeuvre de l'événement
    2013-01-14
  • Date de publication de l'événement
    2013-02-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115498
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Cause
    The recall was initiated because breg has determined that some sterile polar pads products manufactured from january 2010 to october 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
  • Action
    The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory. Should you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.

Device

Device Recall BREG Cold Therapy Combination Units
  • Modèle / numéro de série
    Affected product will be identified by date of manufacture from January 2010 through October 2012.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
  • Description du dispositif
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
  • Manufacturer
    Breg Inc

Manufacturer

Breg Inc