Events

Rappel de Device Recall Hospira Accessory Power Pack

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
    56138
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2234-2010
  • Date de mise en oeuvre de l'événement
    2010-07-02
  • Date de publication de l'événement
    2010-08-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92726
  • 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
    Infusion Pump - Product Code FRN
  • Cause
    The power pack accessory is not certified to ul 60601 standard or subject 1363a for relocatable power taps intended for use with medical equipment. potential problems could include electrical shock, electrical short or electrical fire.
  • Action
    Hospira sent Urgent Device Recall letters dated 7/1/10 to their direct accounts on 7/2/10 via Federal Express 2 day delivery, informing them of the potential for electrical shock, electrical short, or electrical fire, since the power packs were not certified to UL 60601 standard or Subject 1363A of UL standard 1363 for relocatable power taps intended for use with medical equipment. The accounts were instructed to examine their inventory for the affected product and quarantine it immediately, and Stericycle at 1-800-321-7388 to obtain a return kit for returning the affected product. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. They were also requested to complete the enclosed reply form and return it to Hospira by fax at 1-262-577-6921, indicating the amount of product placed on hold for return, if they further distributed the product and if they notified their retail customers. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187.

Device

Device Recall Hospira Accessory Power Pack
  • Modèle / numéro de série
    part number 39003-04-01, lots 102806, 57001G3, 59034G3, 62002G3, and 64009G3.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Description du dispositif
    Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; Distributed by: Hospira, Inc., 275 N. Field Drive, Lake Forest, IL 60045; part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG || Accessory power pack used for use with medical devices.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 375 N Field Dr, Lake Forest IL 60045
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA