Events

Rappel de YType Blood 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
    65689
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1858-2013
  • Date de mise en oeuvre de l'événement
    2013-04-01
  • Date de publication de l'événement
    2013-08-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119891
  • 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, blood transfusion - Product Code BRZ
  • Cause
    It was discovered that there was a potential for the piercing pin on certain hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
  • Action
    Hospira sent an Important Safety Information letter dated April 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exercise EXTREME CAUTION when using Hospira blood bags and to make sure that all instructions for use are included with the blood bag and their facility's protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag. Customers with issues were instructed to call Hospira at 1-800-441-4100 or email ProductComplaintsPP@hospira.com. Customers were asked to complete the attached replay formand return it to the fax number on the form. If customers distributed the product further they were instructed to notify their accounts that received the affected product and ask them to contact Stericycle at 1-866-608-3936 to receive a reply form. Customers with questions were instructed to contact Hospira at 1-800-441-4100. For questions regarding this recall call 224-212-2000.

Device

YType Blood Set
  • Modèle / numéro de série
    List Number: 14219-28;  Lot Number: 962245H
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Puerto Rico and Internationally to Costa Rica.
  • Description du dispositif
    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA || Hospira Blood sets are designed for Blood Product Administration
  • 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