Medline Industries, LP — Class II: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Medline Industries, LP has initiated a Class II recall for certain PPE kits due to calibration issues with equipment used for sterilization and packaging. While products underwent validated cycles, the calibration discrepancy may compromise the sterility assurance level (SAL).
This affects Medline Industries, LP, healthcare providers utilizing the DYK1011945P PPE kits, and quality assurance personnel responsible for sterilization validation and equipment maintenance.
The source indicates a breakdown in equipment calibration oversight, which is a critical component of maintaining validated sterilization processes. For regulatory professionals, this suggests a potential risk to the sterile barrier or microbial kill efficacy, necessitating proactive assessment of affected inventory to mitigate clinical risks associated with non-sterile procedural components.
Quality and sterilization teams should audit equipment calibration records to ensure all validated parameters remain within tolerance. Regulatory departments must verify that sterilization assurance levels (SAL) are not compromised by drift in equipment performance or measurement inaccuracies.
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) PPE KIT, Model Number: DYK1011945P. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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