Events

Rappel de Device Recall Access Point Quad Canes

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
    35920
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0204-2007
  • Date de mise en oeuvre de l'événement
    2006-03-10
  • Date de publication de l'événement
    2006-11-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47151
  • 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
    cane - Product Code IPS
  • Cause
    The canes were made of unacceptable materials and could break.
  • Action
    The firm began making telephone calls and issuing recall letters dated 3/9/06 via UPS on 3/10/06. The telephone call explained the reason for recall and notified the customer they would be receiving a letter requesting return of the canes. The letter additionally notified the customer the recall was to be affected to the retail level. A customer response form was enclosed. The firm issued a second recall letter dated 12/22/06 via registered mail on 12/26/06 explaining the reason for recall, pointing out the hazard involved with the use of the recalled canes, and requesting they cease sales of the product. The letter requested they notify their customers of the recall and to post the enclosed recall placard where it can be seen by returning customers. Recall instructions were enclosed outlining step-by-step instructions for their customer to follow, including destroying the canes on site. A Customer Response Form was also enclosed. The firm issued a third letter dated 1/11/07 via regular mail which included a corrected placard because the product code numbers were incorrect in the placard included with the letter dated 12/22/06. The customers were instructed to discard the previous placard.

Device

Device Recall Access Point Quad Canes
  • Modèle / numéro de série
    All canes bearing the model number.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and Small Base - Chrome, Product Code CN11050C, both packaged 6/case. The responsible firm is Access Point Medical, St. Louis, MO.
  • 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