Events

Recall of Device Recall Texium Closed Male Luer (CML),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 303 Inc DBA Alaris Products.

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
    44826
  • Event Risk Class
    Class 2
  • Event Number
    Z-0218-2008
  • Event Initiated Date
    2007-08-30
  • Event Date Posted
    2007-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64417
  • 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
    Closed Male Luer - Product Code FPA
  • Reason
    Leaks: there is a risk of leakage at the female end of the texium closed male luer (cml) when attached to a spin luer. (note: users who connect the female portion of the texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue).
  • Action
    Recall notification was made via a Safety Alert Notification Letter dated August 30, 2007. Recall will be conducted through consignees (distributors) in the affected countries, as well as, direct customers for the Texium closed male luer. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management, and Director of Pharmacy at each facility. Distributors were sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their sub-account customers. The domestic letters (direct customers and distributors) were mailed on August 30, 2007 to all of the affected accounts. The international notifications will be coordinated out of the offices located in the affected countries. The appropriate international regulatory authorities will be notified of this issue, which will work with the country managers at each location.

Device

Device Recall Texium Closed Male Luer (CML),
  • Model / Serial
    Model Number 10012241 (all lot numbers)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of Arkansas, California, Colorado, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New England, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin. and countries of Australia, Canada, Japan and Switzerland
  • Product Description
    Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Manufacturer Address
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA