Recall Z-0267-2018 ยท KXK Source, Brachytherapy, Radionuclide
C.R. Bard, Inc.
I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | Activity and quantity of seeds sent in shipments were incorrect. |
| Root cause | Other |
| Action | Customers were notified via letter on December 9, 2016. In the case of both customers, the hospital utilized the product to complete the scheduled implants. Adjustments were made to the dose plans and the number of seeds implanted. According to C.R. Bard, the physicians would evaluate the risk by taking into account each individual patient's condition, comorbidities, and treatment plans, and would adjust the dose. For further questions, please call (770) 784-6120. |
| Quantity | 134 seeds |
| Distribution | Belgium & South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043246 | BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS C.R. Bard, Inc., Feb 2, 2005 |