Events

Rappel de Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor

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 Corpak Med Systems.

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
    61036
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1080-2012
  • Date de mise en oeuvre de l'événement
    2012-01-26
  • Date de publication de l'événement
    2012-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107147
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Cause
    The wrong size twoomey adapter was packaged with the jejunal tube.
  • Action
    Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.

Device

Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor
  • Modèle / numéro de série
    catalog/reorder #30-7361, lot 46121, expiration: 2016-10
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.
  • Description du dispositif
    CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition || Product Usage: For delivery of enteral nutrition
  • Manufacturer
    Corpak Med Systems

Manufacturer

Corpak Med Systems
  • Adresse du fabricant
    Corpak Med Systems, 1001 Asbury Dr, Buffalo Grove IL 60089
  • Société-mère du fabricant (2017)
    Halyard Health Inc
  • Source
    USFDA