Events

Recall of Bard BrachySource Seed Implants

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Brachytherapy, 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
    79972
  • Event Risk Class
    Class 2
  • Event Number
    Z-1702-2018
  • Event Initiated Date
    2018-04-10
  • Event Date Posted
    2018-04-27
  • 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=164063
  • 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
    Bard medical division is recalling the bard¿ brachysource¿ iodine125 radioactive seeds in mick¿ applicators and bard¿ brachysource¿ iodine125 radioactive seeds loose in vial with sterile spacers. because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. one hospital ordered brachysource¿ iodine125 0.36 mci radioactive seeds but instead received brachysource¿ iodine125 0.28 mci radioactive seeds and vice versa for the other hospital affected.
  • Action
    The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.

Device

Bard BrachySource Seed Implants
  • Model / Serial
    Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079  Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026  Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : California and Georgia
  • Product Description
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.
  • Manufacturer
    Bard Brachytherapy, Inc.

Manufacturer

Bard Brachytherapy, Inc.
  • Manufacturer Address
    Bard Brachytherapy, Inc., 295 E Lies Rd, Carol Stream IL 60188-9421
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA