BARD¿ BrachySource¿ Iodine125 radioactive seeds consist recall
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated…
Why was BARD¿ BrachySource¿ Iodine125 radioactive seeds consist 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated…
- Recalling firm
- Bard Brachytherapy, Inc.
- Quantity
- 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
- Distribution
- US Distribution to the states of : California and Georgia
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)