Medline Industries recalled 240 units of convenience kits on January 7, 2026. Calibration issues with sterilization equipment may impact product safety. Patients and healthcare providers should stop using these 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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The recall involves two models: Drape Pack (Model Number: DYNJ35363A) and Sick Kids-General Custom Split (Model Number: SPTPCD10005). Both models were distributed worldwide, including across the U.S. and are classified as Class II devices.
The recall stems from calibration issues with the sterilization equipment used for these kits. Although the products underwent validated sterilization, the calibration problems may compromise their sterility assurance level.
No injuries or incidents have been reported related to this recall. The potential risk involves compromised sterility which can affect patient safety.
Stop using the recalled devices immediately. Follow the recall instructions provided by Medline Industries and contact your healthcare provider for further guidance.
For more information, contact Medline Industries, LP. Visit their website or refer to the recall notification letter for specific instructions.
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