Recall: FDA Classifies Oxygen Concentrator as Class I Recall
Nidek Medical Products, Inc. recalled their Medical Mark5 Nuvo Lite Oxygen concentrators for instances of failure causing fire.
Nidek Medical Products, Inc., today announced that the US Food and Drug Administration has classified the company’s voluntary recall of Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall.
The devices were recalled due to capacitor-related fires. According to the FDA, a capacitor component inside the concentrators were, in some instances , found to fail, which has caused residential and nursing home fires, and a loss of oxygen supply.
However, no injuries have been reported.
According to the press release from the FDA, “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.”
Nidek Medical Products, Inc., is currently in the process of notifying its distributors and customers by e-mail and regular mail. More than 95 percent of recipients of affected concentrators have been notified.
Nidek Medical Products, Inc. is supplying affect customers and distributors with replacement capacitors or all affected devices.
Customers should notify their equipment providers if they have an affected device. Consumers with questions can contact Nidek Medical Products, Inc. by phone at 1-205-856-7200 ext 242 or by email at email@example.com.