Events

Rappel de ColorSafe IV Administration sets and components

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 Codan Us Corporation.

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
    68591
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2040-2014
  • Date de mise en oeuvre de l'événement
    2011-08-17
  • Date de publication de l'événement
    2014-07-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128284
  • 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
    Codan us corporation is recalling the colorsafe iv (intravenous) product lines because they were manufactured and marketed prior to fda approval.
  • Action
    CODAN sent a recall letter dated August 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any of the affected product. If they sold the product they should provide Codan the name and address of the customer. so that they may be contacted to retrieve the shipped products. Customers were instructed to contact CODAN Customers Service for a Returned Goods Authorization. Customers with questions were instructed to call 714-430-1303. Customers were instructed to not send used devices.For questions regarding this recall call 714-545-2111.

Device

ColorSafe IV Administration sets and components
  • Modèle / numéro de série
    Lot No.  71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
  • Description du dispositif
    ColorSafe IV lines || Catalog No.(Model No.) || CS3000-R (76.7806), || CS400-R (76.7800), || CS408N-R (76.8000), || CS3000-B (76.7807), || B314 (25.7406), || CS400-B (76.7801), || CS408N-B (76.8001), || CS3000-O (76.7808), || CS400-O (76.7802), || CS408N-O (76.8002), || CS3000-G (76.7809), || CS400-G (76.7803), || CS408N-G (76.8004), || CS3000-P (76.7810), || CS400-P (76.7804), || CS408N-P (76.8003). || Intravenous administration sets
  • Manufacturer
    Codan Us Corporation

Manufacturer

Codan Us Corporation
  • Adresse du fabricant
    Codan Us Corporation, 3511 W Sunflower Ave, Santa Ana CA 92704-6944
  • Société-mère du fabricant (2017)
    Codan Medical Holding Aps
  • Source
    USFDA