Events

Rappel de Device Recall Ambulatory Infusion Pump

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 Zevex International, 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
    57939
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1870-2011
  • Date de mise en oeuvre de l'événement
    2011-02-28
  • Date de publication de l'événement
    2011-04-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97789
  • 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.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
  • Action
    The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patient WARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump. If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.

Device

Device Recall Ambulatory Infusion Pump
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.
  • Description du dispositif
    Curlin PainSmart IOD Ambulatory Infusion Pump || Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Adresse du fabricant
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    USFDA