Events

Recall of ColorSafe IV Administration sets and components

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Codan Us Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68591
  • Event Risk Class
    Class 2
  • Event Number
    Z-2040-2014
  • Event Initiated Date
    2011-08-17
  • Event Date Posted
    2014-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128284
  • Notes / Alerts
    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.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
  • Product Description
    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
  • Manufacturer Address
    Codan Us Corporation, 3511 W Sunflower Ave, Santa Ana CA 92704-6944
  • Manufacturer Parent Company (2017)
    Codan Medical Holding Aps
  • Source
    USFDA