Medtronic Recalls Quick-Set Infusion Sets
Posted on July 14, 2009 @ 07:57 am
Medtronic Inc. has recalled specific Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps, according to the Minneapolis, Minn.-based firm.
An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient and is typically replaced by the patient every three days. Company officials said affected infusion sets have reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers starting with the number eight.
Medtronic recently discovered that about 2 percent of “Lot 8” Quick-set infusion sets, which represents about 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers, may not work properly.
The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.
Visit www.medtronicdiabetes.com/lot8to view the labels of “Lot 8” Quick-set infusion sets. 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.
“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.”
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