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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Medline Convenience Kits are used in healthcare settings for various medical procedures, including dressing changes. They are designed to provide sterile materials necessary for patient care.
The recall is due to calibration issues with sterilization equipment, which may compromise the sterility of the products. This raises the risk of infections for patients.
This recall is not part of a broader industry pattern.
The recall affects a significant number of medical kits, potentially endangering patient safety. Immediate action is required to prevent health risks.
Model numbers and lot numbers are typically found on the packaging or the product label.
Expect a timeline of 4-6 weeks for refund processing after returning the recalled product.
Keep copies of all communication and any receipts related to the purchase and return of the recalled product.
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.
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