Medline Industries recalled 15 units of its Triple Lumen Insertion Kits on January 7, 2026. The recall stems from calibration issues in sterilization equipment that may affect the product's sterility assurance level. Users should cease use immediately and follow manufacturer instructions.
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 Medline Triple Lumen Insertion Kit is a medical device used in various healthcare procedures requiring sterile tools. Consumers typically purchase these kits through medical supply channels for professional use in hospitals and clinics.
The calibration issues with sterilization equipment can compromise the sterility of the kits, potentially exposing patients to infection risks during medical procedures. This is particularly concerning in environments where sterility is critical to patient safety.
This recall is not part of a broader industry pattern.
The recall may create immediate inconvenience for healthcare providers relying on these kits for patient care. Users must stop utilizing the product and seek alternatives to avoid potential health risks.
Model numbers and lot numbers are typically found on the packaging or the product label.
Expect processing for refunds or replacements to take 4-6 weeks.
Keep records of the purchase, any correspondence with the manufacturer, and details of the recall for your reference.
The recalled product is the Triple Lumen Insertion Kit, Model Number DYNDM1031A. It was distributed worldwide, including across the United States. The products were exposed to validated sterilization cycles but may not meet sterility assurance standards.
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