FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0974-05
- Recalling firm
- Theragenics Corporation
- 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.
- Status
- Terminated
- Initiated
- 2005-05-16
- Posted
- 2005-07-07
- Terminated
- 2005-10-05
- 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
- Lot, serial or model codes
- Part Number S-0101; Lot #RR13N101L and RR13N101Q
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KXK
- Firm FEI
- 1037598
- Firm city
- Buford
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28