Affected sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers starting with number 8
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Medtronic has initiated a recall of specific lots of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps.
Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers starting with number 8. Medtronic recently discovered that approximately 2% of Lot 8 Quick-set infusion sets may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly.
Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge.
Chris O’Connell, President of the Diabetes business unit and SVP at Medtronic, said: “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.”
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