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Bard Brachytherapy, Inc. recalls BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a
Recalled May 16, 2018 · FDA recall Z-1702-2018 · Bard Brachytherapy
Hazard
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. · FDA Class II
Units
70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
Sold at
US Distribution to the states of : California and Georgia
Description
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.
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.
Manufacturer(s)
Bard Brachytherapy, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →