Events

Recall of Device Recall I125 CE Marked QuickLink Cartridges

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, Inc..

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
    77439
  • Event Risk Class
    Class 2
  • Event Number
    Z-0267-2018
  • Event Initiated Date
    2016-12-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156058
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • Reason
    Activity and quantity of seeds sent in shipments were incorrect.
  • Action
    Customers were notified via letter on December 9, 2016. In the case of both customers, the hospital utilized the product to complete the scheduled implants. Adjustments were made to the dose plans and the number of seeds implanted. According to C.R. Bard, the physicians would evaluate the risk by taking into account each individual patient's condition, comorbidities, and treatment plans, and would adjust the dose. For further questions, please call (770) 784-6120.

Device

Device Recall I125 CE Marked QuickLink Cartridges
  • Model / Serial
    Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium & South Africa.
  • Product Description
    I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges || Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA