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 / numberProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 5, 2020 · Data as of Sep 19, 6:01 PM UTC

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