Medline Industries, LP — Class II: Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK
Medline Industries, LP has initiated a Class II recall for specific Lithotomy Packs and Lap Basins due to calibration issues with equipment used during the sterilization and packaging processes.
Medical device manufacturers, surgical facility procurement departments, and sterilization validation teams involved with surgical convenience kits.
While the source indicates products underwent validated cycles, the calibration failure undermines the Sterility Assurance Level (SAL). This suggests a potential breakdown in equipment maintenance or monitoring protocols, which may require a review of Quality Management System (QMS) controls regarding calibrated measurement tools in sterile processing environments.
Identify and quarantine all units of specified Lithotomy Packs and Lap Basins; verify equipment calibration logs for all in-house or contract sterilization processes to ensure Sterility Assurance Levels (SAL) are maintained.
Class II. Reason: 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.. Product: Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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