Events

Rappel de Device Recall Aesculap

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 Aesculap, 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
    67174
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0989-2014
  • Date de mise en oeuvre de l'événement
    2013-12-23
  • Date de publication de l'événement
    2014-02-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124863
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Cause
    The accuracy is out of specification for the aesculap prosa adjustment disc size l.
  • Action
    Aesculap sent an Important Correction and Removal Notification dated December 23, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.. Yom"Aesculap Sales Representative will contact you to schedule a time to remove the FV795T from Set FV792T. Please use FV790T in the absence of the FV795T to ensure the correct adjustment has been made. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please call (610) 984-9265 or (610) 984-9414 with any questions.

Device

Device Recall Aesculap
  • Modèle / numéro de série
    4 lots: 4505268906, 4505336973, 4505408485, 4505238953
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.
  • Description du dispositif
    Aesculap proSA Adjustment Disc Size Large (L) || The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Adresse du fabricant
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA