Rappel de Stic Kit Needle Containment Device

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 EM Innovations 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
    36165
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0056-2007
  • Date de mise en oeuvre de l'événement
    2006-04-03
  • Date de publication de l'événement
    2006-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2007-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Stic Kit Needle Containment Device - Product Code MMK
  • Cause
    The firm failed to include user instructions with the stic kit needle containment device, model emi 82691, which they shipped to distributor/customers.
  • Action
    The recalling firm contacted all fifteen (15) of its distributor/customers (not just the distributors that received the affected devices) via telephone on 4/3-5/2006 in order to inform them that the User Instructions had not been included with the needle containment devices that were shipped between 7/5/2005 and 4/3/2006. The firm asked that the distributors check their inventories and if it was determined that User Instructions were missing, report the amount needed to the recalling firm which would in turn send them out. The firm followed up on their recall action via telephone on 7/11/2006, at which time, it was determined that that all of the distributors either had old User Instructions in stock for distribution, or that there were no affected device units left in inventory.

Device

  • Modèle / numéro de série
    The recalled units are identified with the Lot Codes: 070505 and 110602.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled device was shipped to distributor/customers located in the following states: MO, OH, WI, PA and NJ.
  • Description du dispositif
    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    EM Innovations Inc, 6106 Bausch Rd, Galloway OH 43119-9382
  • Source
    USFDA