Medline recalled 553 units of its Convenience Kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using the affected devices 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 use in medical procedures, providing necessary sterile equipment and supplies. They are commonly used in hospitals and healthcare settings for various applications.
The calibration issues with sterilization equipment may lead to inadequate sterilization of the products, increasing the risk of infection for patients.
This recall is not part of a broader industry pattern.
This recall presents a high level of urgency for healthcare providers and patients, as using affected products may compromise patient safety.
Model and lot numbers are usually found on the product packaging or product label.
Expect a refund or replacement processing time of 4-6 weeks after returning the product.
Keep a record of all correspondence, receipts, and photographs of the product.
The recalled models include DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, and CVI4300. These products were distributed worldwide, including throughout the United States. No price information is available.
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