Medline Industries has recalled 779 units of its Convenience Kits due to calibration issues with sterilization equipment. The recall affects multiple model numbers including DYNJ56436A and DYNJ56436B. Consumers should stop using these products immediately and follow recall 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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Medline Convenience Kits are medical supplies used for pain management and surgical procedures. They are designed to ensure patient safety and comfort during medical treatments.
Calibration issues with the sterilization equipment could lead to inadequate sterilization of the devices, risking patient safety due to potential exposure to pathogens.
This recall is not part of a broader industry pattern.
Consumers using these kits should stop immediately to avoid health risks, impacting patient treatment and safety.
Model numbers and lot numbers can typically be found on the product packaging or the device itself.
Expect refund processing to take approximately 4-8 weeks after initiating the return.
Keep a record of your purchase, including receipts and any correspondence related to the recall.
The recalled models include SCC RF PAIN MGMT, Model Numbers: DYNJ56436A, DYNJ56436B, and CPNB SETUP TRAY, Model Numbers: DYNJRA1979, DYNJRA1979A, SAMPA0108. These products were distributed worldwide, including throughout the United States.
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