FDA Issues Recall On Resuscitation Systems with Blenders
February 18, 2013
The U.S. Food and Drug Administration recently announced it would be partnering with medical device manufacturer, GE Healthcare, in conducting the voluntary recall of the resuscitation systems with blenders installed in GE Giraffe and Panda Infant Warmers. According to a press release from the agency, the recall is being conducted due to a malfunction in the device.
The units are used to regulate the amount of gas that is released to a patient through the device. Experts say the device presents a Product Liability issue though, when the oxygen and air wall fittings on the back panel of the device are reversed during assembly. This can lead to the blender knob on the device no longer giving an accurate reading, resulting in a patient potentially getting too much or not enough oxygen. This could result in serious side effects, including death.
Anyone who is in possession of an affected unit has been instructed to contact the manufacturer so that a specialist can inspect the devices for any malfunctions, correct any problems they discover, and replace any units that cannot be fixed.
The Norfolk Injury Lawyers with Lowell “The Hammer” Stanley are hopeful the recall will prevent any patients from being harmed by the defective products, while also promoting medical device manufacturers to ensure their products are safe to by on the market.