FDA-Device2017-12-27Class II
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.
C.R. Bard, Inc.
Hazard
Activity and quantity of seeds sent in shipments were incorrect.
Sold states
Belgium & South Africa.
Affected count
134 seeds
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2018Don't want to check this manually?
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