Z-0974-05

PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103...

Name: Z-0974-05 PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103...
Creator: Theragenics Corporation
Published: 2005-05-16
License: https://open.fda.gov/license/

Theragenics Corp. / initiated 2005-05-16 / Terminated / root cause: labeling and UDI

FDA source

Theragenics Corporation began a 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... on 2005-05-16. The reason FDA records is "The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0974-05
Status: Terminated
Initiated: 2005-05-16
Posted: 2005-07-07
Terminated: 2005-10-05
Recalling firm: Theragenics Corp.
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.
Product code: KXK Source, Brachytherapy, Radionuclide
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were contacted on 5/16/2005 via telephone and email.
Quantity in commerce: 13 loads
Distribution: OH, VA
Product codes and lots: Part Number S-0101; Lot #RR13N101L and RR13N101Q

Product code KXK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)