Events

Rappel de Device Recall Hospira LifeShield LatexFree 100 mL Burette Set

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
    62582
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2075-2012
  • Date de mise en oeuvre de l'événement
    2012-07-13
  • Date de publication de l'événement
    2012-07-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111089
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    The float valve in the burette sticks to the burette wall and does not open or close properly.
  • Action
    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated July 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: hospira4921@stericycle.com; return affected product to Stericycle using the label provided with the letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.

Device

Device Recall Hospira LifeShield LatexFree 100 mL Burette Set
  • Modèle / numéro de série
    list 12722-65, lot number 96-098-5H
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada.
  • Description du dispositif
    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. || Intended use: for the administration of fluids.
  • 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