Medline Industries, LP — Class II: Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline Industries, LP has initiated a Class II recall for specific Medline Convenience Kits (Model DYNJ50806L) due to calibration issues with equipment used during the sterilization and packaging process. while products underwent validated cycles, the calibration errors may have impacted the Sterility Assurance Level (SAL).
This recall affects Medline Industries, LP, healthcare facilities utilizing WMC I D PACK-LF convenience kits, and professionals in medical device quality control and sterilization services.
The source indicates a potential compromise in the SAL, which suggests a theoretical risk of non-sterility despite the products undergoing validated cycles. For regulatory professionals, this underscores the critical dependency of sterilization validation on precise equipment calibration. Failure to maintain calibrated states can invalidate primary sterilization data, necessitating retrospective impact assessments and field corrections to mitigate patient infection risks.
QA and Sterilization teams should confirm that all calibration schedules for sterilization and packaging equipment are strictly adhered to and documented. Regulatory teams should review existing Sterility Assurance Level (SAL) validations to ensure they remain robust even in the event of minor equipment deviations. Procurement departments should identify and sequester affected model DYNJ50806L kits pending further manufacturer instruction.
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) WMC I D PACK-LF, Model Number: DYNJ50806L. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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