Events

Rappel de Device Recall GemStar Medical Power Supply

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
    68047
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0095-2015
  • Date de mise en oeuvre de l'événement
    2014-02-03
  • Date de publication de l'événement
    2014-10-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126857
  • 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
    The gemstar infusion pump may not receive direct current (dc) power from the power supply. in one instance, smoke was observed and the gemstar pump was operating on battery power while connected to the 3 volt dc power supply.
  • Action
    An URGENT MEDICAL DEVICE CORRECTION letter dated February 3, 2014 was sent to all direct accounts. The letter included specific instructions for how to handle and use the power supplies so as to minimize the chance of any device failures. There were additional instructions for customers to: 1) Inform potential users in their organization of the product of this notification; 2) Complete the attached reply form and return it to the fax number or e-mail address on the form (even if you do not have any affected product in inventory); 3) If the products were further distributed, their customers should be notified of the recall and asked to contact Stericycle at 888-641-9735 to receive a reply form; and, 4) if a potential user believes that their power supply is damaged for any reason, it should be removed from service and the user should contact Hospira Global Complaints at 800-441-4100 to report the concern. The letter further notes that there is no need to return fully functional power supplies (unless they malfunction).

Device

Device Recall GemStar Medical Power Supply
  • Modèle / numéro de série
    Wall Mount GemStar Power Supply List Number: 13026; Lot Numbers: 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Description du dispositif
    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
  • 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