Events

Rappel de Device Recall MOOG 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 Zevex Incorporated (dba Moog Medical 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
    78573
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0702-2018
  • Date de mise en oeuvre de l'événement
    2017-11-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159791
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Particulate found on the curlin spike.
  • Action
    The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers. The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.

Device

Device Recall MOOG Curlin Infusion Administration Set,
  • Modèle / numéro de série
    UDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
  • Description du dispositif
    MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. || Product Usage: || Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
  • Manufacturer
    Zevex Incorporated (dba Moog Medical Medical Devices Group)

Manufacturer

Zevex Incorporated (dba Moog Medical Medical Devices Group)
  • Adresse du fabricant
    Zevex Incorporated (dba Moog Medical Medical Devices Group), 4314 S Zevex Park Ln, Salt Lake City UT 84123-7881
  • Source
    USFDA