Rappel de DocUDose

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 Eatonform 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
    36103
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0045-2007
  • Date de mise en oeuvre de l'événement
    2006-08-02
  • Date de publication de l'événement
    2006-10-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-05-21
  • 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
    Medication reminder - Product Code NXQ
  • Cause
    Certain lots of packet components of the firm's doc-u-dose prescription management system are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging.
  • Action
    The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 8/2/2006, 8/4/2006, and 8/11/2006. In their recall notifications, the firm requested that the pharmacy customers: 1) cease using and distributing all Doc-U-Dose packets identified with the recalled lot numbers; 2) segregate and secure all Doc-U-Dose packets identified with the suspect lot numbers on-hand; 3) inform the firm as to whether or not they have any of the suspect product which they would be returning and the quantity of product to be returned; 4) return all packets to Eatonform at the recalling firm¿s expense; and 5) notify their subaccount customers and ask that they cease using the device until such time as the problem is corrected.

Device

  • Modèle / numéro de série
    Four (4) lot codes are subject to recall: 312733, 312734, 313767, and 313768. This accounts for all of the Doc-U-Dose packets distributed by the firm since May 13, 2006.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime.''
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Eatonform Inc, 2280 Arbor Blvd, Dayton OH 45439-1522
  • Source
    USFDA