Events

Rappel de Device Recall Smiths Medical

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 Smiths Medical ASD, 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
    67034
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0645-2014
  • Date de mise en oeuvre de l'événement
    2013-07-10
  • Date de publication de l'événement
    2014-01-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124582
  • 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
    Syringe, antistick - Product Code MEG
  • Cause
    Visible orange/ brown particulate on the needles of the 29g hypodermic needle-pro¿ fixed needle insulin syringes.
  • Action
    The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated July 10, 2013 to its consignees/customers and distributors. The notice described the product, problem and actions to be taken. The Distributors were instructed to notify their customers. The consignees/customers were instructed to inspect your inventory for the suspect lots and remove all affected devices from use and complete and return the Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to FNS@smiths-medical.com within five (5) days of receipt of this notice. If you or your facility has distributed these affected products to other persons or facilities, please promptly forward the recipients of this Urgent Field Safety Notice. Upon receipt of the completed form, a customer service representative will contact you to arrange for exchange of your unused affected devices for credit or replacement. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at 800-258-5361

Device

Device Recall Smiths Medical
  • Modèle / numéro de série
    Lot Numbers: 2356156, 2358706
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.
  • Description du dispositif
    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in || Distributed by: Cardinal Health, Dublin, OH (Co-Brand) || Reference: ED012905-IN || Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA