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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Medline convenience kits are used in healthcare settings for various medical procedures. They typically contain essential sterile components needed for patient care and surgery.
Calibration issues with the sterilization equipment may compromise the sterility of the convenience kits. This can lead to an increased risk of infections in patients if the kits are used.
This recall is not part of a broader industry pattern.
Consumers should cease using the affected convenience kits to avoid potential health risks. This recall highlights the importance of effective sterilization practices in medical devices.
Model numbers and lot numbers are typically found on the product label or packaging.
Expect a response within 4-6 weeks for refunds or replacements after contacting Medline.
Keep records of your purchase, including receipts and any correspondence related to the recall.
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.
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