Medline Industries recalled 30,958 convenience kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must 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 medical device kits used in various healthcare procedures, designed to provide necessary tools for surgeries and other medical interventions. Healthcare providers rely on these kits for efficient and safe patient care.
Calibration issues with the sterilization equipment may lead to compromised sterility, increasing the risk of infection or other health complications for patients. Proper sterility is critical for any medical device used in clinical settings.
This recall is not part of a broader industry pattern.
The recall affects thousands of healthcare providers and patients who rely on these kits for safe medical procedures. The urgency to stop using these products is high due to the potential for serious health risks.
Model numbers and lot numbers can typically be found on the packaging or printed labels attached to the product.
Expect a refund or replacement processing time of approximately 4-6 weeks after submitting your request.
Keep records of your purchase, including receipts and any correspondence regarding the recall for potential claims.
The recall involves various Medline convenience kits, including the OR Arteriogram (Model Number: CDS985094F) and additional kits for cardiac procedures. These products were distributed globally and are associated with potential sterility issues.
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