Events

Rappel de Device Recall Hospira LifeCare PCA Label Utility, Version 1.0

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 Hospira 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
    46846
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1181-2008
  • Date de mise en oeuvre de l'événement
    2008-01-03
  • Date de publication de l'événement
    2008-08-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68332
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    pharmacy compounding software - Product Code MEA
  • Cause
    Incorrect dosage labels created: customers have experienced independent changes in drug concentration (mg/ml to mcg/ml and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.
  • Action
    Hospira sent letters dated 1/3/08 to the immediate recipients of the product via FedEx overnight letter on the same date. The letters informed the accounts of the reports of independent changes in drug concentration while editing a saved formulation using the Hospira LifeCare PCA Label Utility Software CD that was provided to some customers in a Hospira MedNet Drug Library Creation Team Introductory Kit-LifeCare PCA kit. The accounts were requested to remove the utility from any PC in their facility on which it is currently installed, destroy the CD and sign and return the enclosed removal verification form verifying that they have removed the software from their system. The letter listed commercially available software packages that the account could validate and implement in their facility. Any questions concerning the utility software withdrawal were directed to Hospira at 1-800-241-4002, option 4, then option 1.

Device

Device Recall Hospira LifeCare PCA Label Utility, Version 1.0
  • Modèle / numéro de série
    Version 1.0, all CDs
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and Canada
  • Description du dispositif
    Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA