The first week of July, Medtronic, Inc. (NYSE:MDT) recalled specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. 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. Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work.
This recall involves Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of "Lot 8" Quick-set infusion sets.
Product problems should be reported to the Diabetes business at Medtronic by calling
800-345-8139 at any time. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
If you or a family member is injured by a product, you need to get immediate medical care. If there is a significant affect or injury, you should contact an attorney concerning the problem. Early investigation can include the collection of product, checking recall alerts, and the proper notifying of those who caused the problem.
