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U.S. Department of Health and Human Services

Safety

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Paradigm Quick-set Plus Insulin Administration Set

Audience: Healthcare professionals, hospital risk managers

FDA and Medtronic, Inc. notified healthcare professionals of a Class I recall of Quick-set Plus infusion sets because of problems with bending of the infusion set's cannula or unintentional disconnection of the set at the insertion site that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations.

[May 20, 2004 - Recall Notice - FDA]
[May 18, 2004 - Press Release - Medtronic, Inc.]