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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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.
Calibration issues with the sterilization equipment could compromise the sterility assurance level (SAL) of the recalled products. This situation poses a significant health risk, particularly for patients receiving medical treatment.
As of the report date, no specific incidents or injuries have been documented related to the use of the recalled products. The risk remains high due to the potential for compromised sterility.
Users must stop using the recalled devices immediately. Contact Medline Industries or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.
For more information, contact Medline Industries at their official website or customer service number.
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