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.
Recall
- Recall Number
- Z-0267-2018
- Event Number
- 77439
- Firm
- C.R. Bard, Inc.
- FEI Number
- 1018233
- Product Code
- KXK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 9, 2016
- Terminated
- April 24, 2020
- Address
- 8195 Industrial Blvd NE, Covington, GA, 30014-1497
Description
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.
Activity and quantity of seeds sent in shipments were incorrect.
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.
Belgium & South Africa.
134 seeds