BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a n
FDA device recall Z-1702-2018 · posted 2018-04-27 · Terminated
Recall details
- Recalling firm
- Bard Brachytherapy, Inc.
- Reason for recall
- 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.
- Action taken
- The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. 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. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KXK
- Quantity affected
- 70 Seeds at 0.28mCi and 100 seeds at 0.36mCi
- Distribution
- US Distribution to the states of : California and Georgia
- Date initiated
- 2018-04-10
- Date posted
- 2018-04-27
- Date terminated
- 2020-06-05
- Location
- Carol Stream, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RADIONUCLIDE BRACHYTHERAPY SOURCE (K093663) | C.R. Bard, Inc. | 2009-12-23 |