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06-19-2012, 11:40 AM #1
Nidek Medical Products, Inc. issues an Urgent Medical Device Correction affecting oxy
Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.