www.fdanews.com/articles/119992-medtronic-manufacturing-change-results-in-infusion-set-recall
Medtronic Manufacturing Change Results in Infusion Set Recall
August 28, 2009
A silicone lubricant added to the manufacturing process has led to a Class I recall of nearly 3 million Medtronic Quick-set infusion sets.
The company began adding silicone lubricant to the sets used to deliver insulin from a pump about 18 months ago to address customer complaints about noise when a set is screwed into an insulin pump. The noise does not affect functionality, Medtronic spokesman Steve Sabicer said.
The lubricant clogged vents, preventing the MiniMed Paradigm insulin pumps used with the sets from venting properly, Sabicer said. The company stopped using the lubricant in June.
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