Medline Industries, LP has recalled 2,740 units of various Medline Convenience Kits, including surgical oncological excision and biopsy trays, due to calibration issues with equipment used during sterilization and packaging. While the products underwent standard sterilization cycles, the calibration error means the sterility of these medical kits cannot be guaranteed. The affected kits were distributed in the United States and include various model numbers such as DYKMBNDL84A and DYNJ48539.
The identified calibration issues may have compromised the Sterility Assurance Level (SAL) of the medical instruments and components within the kits. Using a non-sterile medical device during surgical or biopsy procedures significantly increases the risk of patient infection or other healthcare-associated complications.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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