C.R. Bard, Inc. recalls I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated fo…
- Recall date
- December 9, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0267-2018
- FDA classification
- Class II
- Brand / firm
- C.R. Bard, Inc.
- Sold / distributed
- Belgium & South Africa.
Why it was recalled
Activity and quantity of seeds sent in shipments were incorrect.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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