FDA Medical Device Recalls (openFDA)
Bard Brachytherapy, Inc.: BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.
- Recall number
- Z-1702-2018
- Recalling firm
- Bard Brachytherapy, Inc.
- Product
- BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons.
- Status
- Terminated
- Initiated
- 2018-04-10
- Posted
- 2018-04-27
- Terminated
- 2020-06-05
- Reason
- Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. Because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. One Hospital ordered BrachySource Iodine125 0.36 mCi radioactive seeds but instead received BrachySource Iodine125 0.28 mCi radioactive seeds and vice versa for the other hospital affected.
- Root cause
- Labeling mix-ups
- Action
- The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. Bard Medical Division is recalling the BARD BrachySource Iodine125 Radioactive Seeds in Mick Applicators and BARD BrachySource Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.
- Quantity
- 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
- Distribution
- US Distribution to the states of : California and Georgia
- Lot, serial or model codes
- Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079 Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026 Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.
- 510(k) numbers
- ["K093663"]
- PMA numbers
- not on file
- Product code
- KXK
- Firm FEI
- 3002942387
- Firm city
- Carol Stream
- Firm state
- IL
- 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