Events

Rappel de Device Recall Curlin Ambulatory Volumetric 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 MOOG Medical Devices Group.

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
    72923
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0688-2016
  • Date de mise en oeuvre de l'événement
    2015-12-23
  • Date de publication de l'événement
    2016-02-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142508
  • 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
    Moog is recalling curlin 4000, 6000, and painsmart infusion pumps manufactured or serviced by mmdg between march 18, 2015 and november 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.
  • Action
    Moog Medical Device Group sent an "Urgent Recall Notice" dated December 22, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove all of their current Calibration Sets from service before placing these new sets into service. Customers were also instructed to complete and return the Recall Reply Form by fax: 801-264-1051 or email to: MoogMedicalSupport@moog.com and for any questions, please contact: Moog Regulatory Affairs at 801-264-1001. For additional information or clarification call 801-264-1001, ext. 112 or via email at: cdodge@moog.com Monday through Friday, 8:00 AM to 5:00 PM, Mountain Time.

Device

Device Recall Curlin Ambulatory Volumetric Infusion Pump
  • Modèle / numéro de série
    All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
  • Description du dispositif
    Moog Curlin Infusion, Ambulatory Infusion Pump || The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. || Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Adresse du fabricant
    MOOG Medical Devices Group, 4314 S Zevex Park Ln, Salt Lake City UT 84123-7881
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    USFDA