Medline has expanded a correction involving procedure kits containing its Medtronic aortic root cannulas, due to risk of serious injury or death.
The expanded recall comes after Medline confirmed more kit types may contain cannulas with excess material in the male luer, which could lead to severe outcomes, including delayed procedures, neurological injury, stroke or death, according to a June 23 news release from the FDA. The recall remains a correction, not a removal, meaning kits can still be used if the faulty cannula is removed and replaced.
Customers were first notified Feb. 21 and instructed to identify affected inventory and apply correction labels instructing staff to remove the recalled component prior to use.
No injuries or deaths have been reported.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.