Medline Convenience Kits chest/breast-LF recalled for potential sterility issues
Check Medline Convenience Kit lot numbers
Medline Industries has recalled certain Chest/Breast-LF Convenience Kits (Model DYNJ83950) because equipment used to sterilize and package them had calibration problems. While the kits went through sterilization cycles, the calibration issues may have affected whether they meet required sterility standards. No injuries have been reported.
- Check if you have a Medline Convenience Kit Model DYNJ83950 with lot numbers 24DBT832, 24CBH626, 23LBR075, 23FBF248, or 23CBG610
- Stop using any kits matching these lot numbers
- Contact Medline Industries or your supplier for instructions on return or replacement
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2026More Medline Industries, LP recalls
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