Events

Rappel de Device Recall Hospira Inc. a Pfizer company

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
    73104
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0863-2016
  • Date de mise en oeuvre de l'événement
    2015-12-22
  • 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=143072
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    Potential for the symbiq pole clamp assemblies to be missing the rubber stop pad.
  • Action
    On December 22, 2015 Stericycle, Inc. sent an URGENT MEDICAL DEVICE CORRECTION notification to direct consignees of record via traceable mailing. The notification included a description of the recall, risk to health information and necessary actions to be performed by the direct account. These include: an inspection of the affected devices for missing rubber stop pad on the Symbiq pole clamp assemblies at the direct accounts.If missing rubber stop pads were discovered they were advised to contact Hospira's Advanced Knowledge Center at 1-800-241-4002, option 4, to receive a replacement pole clamp assembly or be directed to a field Service Engineer who will replace the pole clamp. Hospira ALso advised informing healthcare professionals at their institution about the issue and complete the attached reply form and return it by e-mail or fax at: 1-800-441-4100/1-800-241-4002 or at ProductComplaintsPP@hospira.com Finally customers where advised to notify FDA of any adverse events through FDA's MedWatch Adverse Event Reporting program.

Device

Device Recall Hospira Inc. a Pfizer company
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. consignees nationwide.*** Foreign consignees in: Canada.
  • Description du dispositif
    The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.
  • 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