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.
FDA Recall Z-0267-2018 · Posted None
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Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeKXK
Date Initiated2016-12-09
Date Terminated2020-04-24
Product Quantity134 seeds
Reason for Recall
Activity and quantity of seeds sent in shipments were incorrect.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Belgium & South Africa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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