Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. Healthcare providers and patients should stop using these kits 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 various surgical procedures, providing essential tools and materials for healthcare providers. These kits are crucial for ensuring sterile environments during surgeries, making them vital in medical settings.
The calibration issues with sterilization equipment mean that the kits may not have been properly sterilized, which increases the risk of infections during procedures. This defect compromises the integrity of the surgical kits and their safety for use.
This recall is not part of a broader industry pattern.
The recall affects a wide range of surgical kits that could potentially compromise patient safety. Immediate action is necessary to prevent risks associated with infections, leading to healthcare challenges.
Model numbers and lot numbers can be found on the packaging of the kits or on the product labels.
Expect a timeline of 4-6 weeks for refund processing after returning the recalled kits.
Keep all correspondence regarding the recall, including receipts and return confirmations. Document any adverse effects experienced after using the kits.
The recall includes 31 models of Medline Convenience Kits, such as the BAP North Robotic Surgery CDS (Model Number: CDS982407N) and various D&C Packs. These products were distributed worldwide, including the U.S., and were sold under Medline Industries, LP.
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