Class 3 Device Recall

• Date Initiated by Firm: May 16, 2005
• Date Posted: July 07, 2005
• Recall Status: Terminated on October 05, 2005
• Recall Number: Z-0974-05
• Recall Event ID: 32194
• Product Classification: Source, Brachytherapy, Radionuclide - Product Code KXK
• Product: 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.
• Code Information: Part Number S-0101; Lot #RR13N101L and RR13N101Q
• FEI Number: 1037598
• Recalling Firm/ Manufacturer: Theragenics Corporation; 5203 Bristol Industrial Way; Buford GA 30518-1799
• For Additional Information Contact: Janet Zeman; 770-271-0233
• Manufacturer Reason for Recall: The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.
• FDA Determined Cause: Other
• Action: Consignees were contacted on 5/16/2005 via telephone and email.
• Quantity in Commerce: 13 loads
• Distribution: OH, VA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.