Events

Rappel de Device Recall ENDURANCE HD

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 Essential Medical Supply, 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
    54810
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2269-2010
  • Date de mise en oeuvre de l'événement
    2009-12-21
  • Date de publication de l'événement
    2010-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89229
  • 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 Walker - Product Code ITJ
  • Cause
    Essential medical supply, inc. is recalling w1801b and w1801r endurance hd walkers due to recent reports and tests that show the front caster may detach from the frame. the potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame.
  • Action
    All Consignees were mailed an Urgent: Product Recall W1801B and W1801R Endurance HD Walkers notification on December 30, 2009. All notifications were sent first class mail in a 9" X 6" envelope. Response cards were included. The letter identified the affected product and the reason for recall. Customers were asked to examine their inventory for affected product and to discontinue further use or distribution of the product. If the product was further distributed, customers should contact their customers, advise them of the recall and have them return the units to them. Customers should follow the instructions provided for return and replacement of units.

Device

Device Recall ENDURANCE HD
  • Modèle / numéro de série
    All SS Numbers 05F0002740 to RPN090702497.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. || Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. || W1801R-Red, UPC 7 54756 91803 3 all serial numbers. || The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. || Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. || Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.
  • Manufacturer
    Essential Medical Supply, Inc.

Manufacturer

Essential Medical Supply, Inc.
  • Adresse du fabricant
    Essential Medical Supply, Inc., 6420 Hazeltine National Dr, Orlando FL 32822
  • Société-mère du fabricant (2017)
    Essential Medical Supply Inc
  • Source
    USFDA