Events

Rappel de Device Recall Stryker MSeries Stretcher

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 Stryker Medical Div. of Stryker Corporation.

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
    55139
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2184-2010
  • Date de mise en oeuvre de l'événement
    2010-03-19
  • Date de publication de l'événement
    2010-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90003
  • 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
    Powered Wheeled Stretcher - Product Code INK
  • Cause
    The retractable cord stretchers were fitted with power cords, manufactured by electri-cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.
  • Action
    The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.

Device

Device Recall Stryker MSeries Stretcher
  • Modèle / numéro de série
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.
  • Description du dispositif
    Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA