Medline Industries recalled 15 units of its Triple Lumen Insertion Kits on January 7, 2026. The recall stems from calibration issues in sterilization equipment that may affect the product's sterility assurance level. Users should cease use immediately and follow manufacturer instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Triple Lumen Insertion Kit, Model Number DYNDM1031A. It was distributed worldwide, including across the United States. The products were exposed to validated sterilization cycles but may not meet sterility assurance standards.
Calibration issues with the sterilization equipment raise concerns about the sterility assurance level of the kits. This could lead to potential health risks if the devices are used in medical settings.
No specific incidents have been reported related to this recall. The potential impact on sterility poses a high risk for users.
Stop using the recalled kits immediately. Contact Medline Industries or your healthcare provider for further instructions. Follow the recall instructions provided via letter.
For more details, contact Medline Industries, LP. Visit the recall notice at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1407-2026.
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