Device product
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.
Z-0267-2018
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 77439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 134 seeds
- Official record key
device-enforcement:Z-0267-2018
Official wording
Reason: Activity and quantity of seeds sent in shipments were incorrect.
Code information: Product Code: 1251QCSCE, Lot No. BBAY0072, BBAY0079, BBAY0090, BBAY0071, BBAY0073.
Distribution pattern: Belgium & South Africa.
Derived failure modes
-
Unknown
Activity and quantity of seeds sent in shipments were incorrect.