Recall Z-1702-2018 ยท KXK Source, Brachytherapy, Radionuclide
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
| Date | Apr 27, 2018 (initiated Apr 10, 2018) |
| Status | Terminated |
| 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 (77 |
| Quantity | 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi |
| Distribution | US Distribution to the states of : California and Georgia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. Bard, Inc., Dec 23, 2009 |