Reported May 16, 2018 · Terminated
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto…
Bard Brachytherapy, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Brachytherapy, Inc. · 295 E Lies Rd · Carol Stream, IL · 60188-9421
Is this the product you have?
- 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.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 1251CSRALot BBCP0079 , BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with PS1251LSLot BBCQ0026 , Loose BrachySource¿ Seed Implants (with — Lot BBCQ0050) Spacers (with — Lot 23498276) 100 Seeds at 0.36 mCi. - Amount recalled
- 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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