Events

Rappel de Device Recall Curlin Infusion Administration Set

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
    61446
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1405-2012
  • Date de mise en oeuvre de l'événement
    2012-03-20
  • Date de publication de l'événement
    2012-04-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108268
  • 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
    Ambulatory administration sets used with the curlin ambulatory pumps including the 4000 cms ambulatory pump, 6000 cms ambulatory pump and the pain smart iod ambulatory pump may leak during use.
  • Action
    Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.

Device

Device Recall Curlin Infusion Administration Set
  • Modèle / numéro de série
    Product Number: 340-4128 Lot Numbers: CF1120913,,, CF1120215,,, CF1120217,,, CF1122238,,, CF1123011,,, CF1123013,,, CF1123010,,, CF1123501,,, CF1123503,,, CF1123502,,, CF1123504,,, CF1123505,,, CF1123507,,, CF1125504,,, CF1125508,,, CF1125505,,, CF1125506,,, CF1125507,,, CF1126301,,, CF1126302,,, CF1126303,,, CF1126305,,, CF1126304,,, CF1126306,,, CF1120216,,, CF1126307,,, CF1127111,,, CF1127112,,, CF1127913,,, CF1127914,,, CF1127915,,, CF1128507,,, CF1128508,,, CF1128509,,, CF1128511,,, CF1128510,,, CF1129201,,, CF1129202,,, CF1129203,,, CF1129204,,, CF1129205,,, CF1130602,,, CF1130603,,, CF1130604,,, CF1131107,,, CF1132012,,, CF1132013,,, CF1132251
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
  • Description du dispositif
    Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

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