Events

Rappel de Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

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 Action Products Incorporated.

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
    28201
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0709-04
  • Date de mise en oeuvre de l'événement
    2004-02-02
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31369
  • 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
    Accessories, Wheelchair - Product Code KNO
  • Cause
    Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
  • Action
    The recalling firm notified dealers by certified letter on 1/19/03. The notification was flagged Attention:Product Recall and advised of seat base susceptibility to cracks and breakage. Dealers were intructed to respond with end user information. Dealers were also provided instructions and materials for crossbar and safety lock installation used with the drop seat bases. Dealers were additionally instructed to forward the provided notification letters to end users.

Device

Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Dr...
  • Modèle / numéro de série
    Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.
  • Description du dispositif
    Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
  • Manufacturer
    Action Products Incorporated

Manufacturer

Action Products Incorporated
  • Adresse du fabricant
    Action Products Incorporated, 22 N Mulberry St, Hagerstown MD 21740-4910
  • Source
    USFDA