Medline Industries recalled 9,720 convenience kits on January 7, 2026, due to sterilization calibration issues. The affected products may not meet sterility assurance levels. Patients and healthcare providers should stop using these kits immediately.
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 recall involves three products: LVAD Driveline Tray (Model DM1035A), LVAD Driveline Tray (Model DM1035), and Central Line Dressing Change Tray (Model DT8670A). These products were distributed worldwide, including the U.S. All kits were exposed to validated sterilization cycles.
Calibration issues with sterilization equipment could compromise the sterility assurance level (SAL) of the recalled products. Affected products may pose a risk of infection or other health complications.
No specific incidents or injuries have been reported. However, the potential for compromised sterility raises serious health concerns.
Stop using the recalled products immediately. Contact Medline Industries or your healthcare provider for further instructions and possible return or refund.
For more information, call Medline Industries at 1-800-633-5463 or visit their website at www.medline.com.
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