Medline Industries, LP recalled 684 medical convenience kits on January 7, 2026. The recall affects the LVAD Driveline Tray and the KIT Surg Onc Insert Cent. Venou due to calibration issues impacting sterility. Health providers and patients should stop using these products 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 designed for medical procedures, providing necessary instruments and supplies. These kits are utilized by healthcare providers to ensure sterile conditions during surgeries and treatments.
Calibration issues with the sterilization equipment can lead to inadequate sterilization levels. This compromises the safety and efficacy of the medical devices included in the kits.
This recall is not part of a broader industry pattern.
Patients using these kits may face health risks if the devices are not adequately sterilized. The urgency to halt use reflects the potential danger in medical settings.
Model numbers and lot numbers are typically printed on the product packaging or the devices themselves.
Expect a refund processing timeline of approximately 4-6 weeks after following the recall instructions.
Keep all receipts, correspondence with Medline, and photographs of the product as evidence for your records.
The recall includes the LVAD Driveline Tray, Model Number: DM1035, and the KIT Surg Onc Insert Cent. Venou, Model Number: DYKMBNDL43. The products were distributed worldwide, including nationwide in the US.
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