Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Customers are being asked to return any affected infusion sets to the company.
“Lot 8” Quick-set infusion sets were distributed in the US, and in limited quantities in a small number of countries outside of the US.
“Our commitment to patient safety is our top priority,” said Chris O’Connell, president of the Diabetes business unit and senior vice president at Medtronic. “We are focused on ensuring that patients and clinicians have up-to-date information and access to replacement infusion sets. We are working closely with the FDA, and our goal is to make this product exchange as timely and as easy as possible for patients.”
