FDA Warning Letters
This article was originally published in The Silver Sheet
Executive Summary
WARNING LETTERS: Medtronic cited for QS and MDR violations in relation to its SynchroMed II infusion pumps and MiniMed Paradigm insulin pumps
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Medtronic recalls infusion sets
Medtronic is recalling specific lots of its Quick-set infusion set used with MiniMed Paradigm insulin pumps. The set is a replaceable plastic tube that delivers insulin from the pump to the patient. Medtronic recently discovered that about 2 percent of the sets in a lot of about 60,000 may not allow the pump to vent air properly, which could cause the device to deliver the wrong amount of insulin. Medtronic is advising patients to check http://www.medtronicdiabetes.com/ to see which box numbers have been recalled. The company will replace the affected products for free. Medtronic estimates about 3 million Quick-set sets are currently in use. Meanwhile, the company received a June 1 FDA warning letter in relation to its MiniMed pumps. (See "Warning Letters"
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