Recall Z-0974-05 ยท KXK Source, Brachytherapy, Radionuclide
Theragenics Corporation
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.
| Date | Jul 7, 2005 (initiated May 16, 2005) |
| Status | Terminated |
| Reason | The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date. |
| Root cause | Other |
| Action | Consignees were contacted on 5/16/2005 via telephone and email. |
| Quantity | 13 loads |
| Distribution | OH, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.