Events

Rappel de Device Recall Medline Excel Shuttle Wheelchair, 26" Wide

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 Medline Industries 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
    47781
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1771-2008
  • Date de mise en oeuvre de l'événement
    2008-03-31
  • Date de publication de l'événement
    2008-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70162
  • 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
    Mechanical Wheelchair - Product Code IOR
  • Cause
    Injuries to fingers. there is a potential for users to pinch their fingers between the seat bars when opening the wheelchairs. the injuries can be severe from fracture to severing.
  • Action
    A Voluntary Field Correction letter dated 3/31/08 was issued to customers. The letter informed them of reports of users catching their fingers under the seat bars, which are identified on the chair with warning stickers. The customers were requested to change the backrest with the enclosed replacement upholstery kit, properly dispose of the old back rest, and place the enclosed cautionary tags on both sides of the chair seat. Instructions for installation of the upholstery and cautionary tags were included, as was a sheet entitled "How to Open a Wheelchair" which gives step by step instructions with illustrations for opening the wheelchair, as well as the warning "CAUTION KEEP YOUR FINGERS ON TOP OF THE UPHOLSTERY AT ALL TIMES. DO NOT PLACE YOUR FINGERS ON THE SIDES OR BOTTOM OF THE CHAIR SEAT." The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the serial numbers of chairs corrected. Any questions were directed to 800-633-5463, extension 5349, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall.

Device

Device Recall Medline Excel Shuttle Wheelchair, 26" Wide
  • Modèle / numéro de série
    Item numbers MDS809700 and MDS809750, all wheelchairs purchased between 12/01/2005 and 08/31/2007
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- including USA and Canada.
  • Description du dispositif
    Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; || Item #MDS809700 comes with Removable Full-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. || item #MDS809750 comes with Removable Full-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source
    USFDA