Cook Incorporated is recalling approximately 18,939 units of various medical devices, including biopsy needles, centesis needles, and dilators, because the sterile packaging may have low seal strength. If the packaging seals fail, the devices can lose their sterility, which could lead to patient infections during medical procedures. These devices were distributed worldwide between late 2023 and early 2024 and are used for various surgical and diagnostic procedures such as biopsies and catheter placements.
A weak seal on the device packaging can allow bacteria or other contaminants to enter the sterile barrier. Using a non-sterile device during an invasive procedure can cause serious infections or inflammatory responses in patients.
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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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