Medline Industries, LP — Class II: See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Num
Medline Industries, LP has initiated a Class II recall for specific Medline Convenience Kits due to calibration issues with equipment used for sterilization and packaging. While products underwent validated cycles, the calibration errors may have compromised the Sterility Assurance Level (SAL) of the finished devices.
This recall affects Medline Industries, LP, healthcare facilities utilizing the specified convenience kits (including plastic bins and specialized surgical kits), and personnel responsible for sterile supply chain and inventory management.
A potential failure in sterility assurance poses a risk of post-operative infection or surgical complications. From a regulatory perspective, this suggests a breakdown in equipment calibration controls within the manufacturing or sterilization process, requiring a review of quality management system (QMS) oversight for validated cycles.
Quality teams should verify the calibration status of third-party or in-house sterilization equipment and evaluate the potential impact on Sterility Assurance Levels (SAL). Regulatory and supply chain departments should identify and quarantine affected convenience kits by model number to prevent clinical use.
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: See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182;. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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