Events

Rappel de Device Recall Access Point Medical Heavy Duty Rollator with Curved Back

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 Access Point Medical 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
    35919
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0155-2007
  • Date de mise en oeuvre de l'événement
    2006-06-20
  • Date de publication de l'événement
    2006-11-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47147
  • 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
    Rolling Walker - Product Code ITJ
  • Cause
    The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.
  • Action
    The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.

Device

Device Recall Access Point Medical Heavy Duty Rollator with Curved Back
  • Modèle / numéro de série
    All Rollators of this model number
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
  • Manufacturer
    Access Point Medical LLC

Manufacturer

Access Point Medical LLC
  • Adresse du fabricant
    Access Point Medical LLC, Three City Place Drive, Suite 750, St. Louis MO 63141
  • Source
    USFDA