Medline Industries, LP recalled 154,427 Convenience Kits on January 7, 2026. The recall stems from calibration issues with sterilization equipment, potentially affecting sterility assurance. Patients and healthcare providers should stop using the affected 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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The recalled products include various models such as ACC010326, ACC010326A, and CDS860063U among others. The kits were distributed worldwide, primarily across the United States. Retail prices for these medical kits vary widely depending on the specific kit.
Calibration issues with the sterilization equipment may compromise the sterility of the products. This raises concerns about the potential for infections and other complications in patients receiving care with these kits.
As of now, there are no reported injuries or incidents associated with the use of these kits. However, the potential for harm exists due to compromised sterility.
Stop using the recalled kits immediately. Contact Medline Industries, LP or your healthcare provider for further instructions and to arrange for product return.
For more information, call Medline Industries at 1-800-396-3991 or visit their website at www.medline.com. Additional details on the recall can be found at the FDA's website.
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