Events

Rappel de Device Recall GemStar Bolus Cord

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
    61472
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1463-2012
  • Date de mise en oeuvre de l'événement
    2012-03-28
  • Date de publication de l'événement
    2012-04-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108180
  • 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
    Hospira has received customer reports of bolus delivery failures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the bolus cord.
  • Action
    Hospira, sent an "URGENT DEVICE FIELD CORRECTION RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to take care when removing the bolus cord from the base of the GemStar unit, inspect the cord for damage, discontinue using any damaged cords, and to call Hospira at 1-800-241-4002 for replacement. A Reply Form was enclosed for customers to complete and return via fax to 1-866-912-7085 or e-mail to: Hospira2627@stericycle.com. Contact Hospira Customer Care at 1-877-946-7747 for technical assistance.

Device

Device Recall GemStar Bolus Cord
  • Modèle / numéro de série
    List Number 13027, all units
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nola, Norway, Oman, Philippines, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay and Venezuela.
  • Description du dispositif
    GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; || An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.
  • 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