Carol Stream, IL, United States
Bard Brachytherapy, Inc. recalls
1 recall recorded since 2018, most recently on 10 April 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 April 2018
- Terminated
- 5 June 2020
- 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.
- Distribution
- US Distribution to the states of : California and Georgia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1702-2018
- 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-li
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.