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.
Reported: December 27, 2017 Initiated: December 9, 2016 #Z-0267-2018
Product 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.
Reason for Recall
Activity and quantity of seeds sent in shipments were incorrect.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 134 seeds
- Distribution
- Belgium & South Africa.
- Location
- Covington, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by C.R. Bard, Inc.. Units affected: 134 seeds.
Why was this product recalled? ▼
Activity and quantity of seeds sent in shipments were incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2017. Severity: Moderate. Recall number: Z-0267-2018.
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