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FDA and Medtronic Issue Class I Recall of Quick-Set Plus Infusion Sets
(05-20-2004) - 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.
Read the MedWatch 2004 Safety Summary, including links to the FDA/CDRH recall notice and Medtronic press release, at
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#paradigm
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