Events

Rappel de Device Recall HeaterBaum Foot & Ankle Heating Pad

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 Ergoactives, 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
    74078
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2137-2016
  • Date de mise en oeuvre de l'événement
    2016-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146226
  • 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
    Pad, heating, powered - Product Code IRT
  • Cause
    Products are marketed without a cleared 510k.
  • Action
    Customers were notified by phone on 01/19/2016. Two follow-up notifications were sent to customers via e-mail. Customers were asked to immediately examine their inventory for the affected product; and, to notify and identify any customers they may have further distributed to. Ergoactives LLC requests that all Heaterbaum products be sent back to their headquarters: 20725 NE 16th Avenue, Suite A-26, Miami, FL 33179, along with the order number and note of where the product was purchased. The enclosed response form should be completed and returned as well. If customers have any questions, they can call Ergoactives LLC at (305)359-5031. Customers will receive a full refund for the return of their Heaterbaum products.

Device

Device Recall HeaterBaum Foot & Ankle Heating Pad
  • Modèle / numéro de série
    All lots; UPC: 862821000030.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.
  • Description du dispositif
    HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
  • Manufacturer
    Ergoactives, Llc

Manufacturer

Ergoactives, Llc
  • Adresse du fabricant
    Ergoactives, Llc, 20725 NE 16th Ave Ste A26, Miami FL 33179-2132
  • Société-mère du fabricant (2017)
    Ergoactives Llc
  • Source
    USFDA