Bard Peripheral Vascular Inc. is recalling 60 units in the U.S. and over 5,000 units internationally of BARD MAGNUM Disposable Core Tissue Biopsy Needles due to packaging damage including indentations and cuts. This damage occurred during the manufacturing process and may have compromised the sterile barrier of the needles. These needles are used with the Magnum Biopsy System to take tissue samples from organs like the liver, kidney, prostate, and breast. If the sterile barrier is broken, using the device could lead to serious infections in patients.
The packaging cuts and indentations can allow microorganisms to enter the package, compromising the sterility of the biopsy needle. Using a non-sterile needle for deep tissue biopsies can introduce bacteria directly into internal organs, potentially causing life-threatening infections or sepsis.
Quarantine and return affected product.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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