Events

Recall of PG910 Spacers, Part number SP101, loaded into Bard¿ Express Seeding Cartridges containing TheraSeed¿ Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Theragenics 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
    32194
  • Event Risk Class
    Class 3
  • Event Number
    Z-0974-05
  • Event Initiated Date
    2005-05-16
  • Event Date Posted
    2005-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39349
  • 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
    The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.
  • Action
    Consignees were contacted on 5/16/2005 via telephone and email.

Device

PG910 Spacers, Part number SP101, loaded into Bard¿ Express Seeding Cartridges containing TheraSe...
  • Model / Serial
    Part Number S-0101; Lot #RR13N101L and RR13N101Q
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    OH, VA
  • Product Description
    PG910 Spacers, Part number SP101, loaded into Bard¿ Express Seeding Cartridges containing TheraSeed¿ Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.
  • Manufacturer
    Theragenics Corporation

Manufacturer

Theragenics Corporation
  • Manufacturer Address
    Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518-1799
  • Source
    USFDA