FDA Device recall Z-1702-2018
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-co…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-co… by Bard Brachytherapy, citing bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1702-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-10 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Brachytherapy |
| Distribution | CA, GA |
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.
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.
Identifiers
| code_info | Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP007…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1702-2018%22
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