Parker Waichman LLP Comments on OxyTOTE Oxygen System Regulators Class I Recall

A Class 1 designation means that exposure to the recalled device presents a reasonable risk of serious injury or death; it is the U.S. Food and Drug Administration's (FDA's) most serious recall status.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, comments on a Class 1 recall announced for Western Enterprises’ Oxytote Oxygen System regulators. According to a July 20, 2015 recall notice posted by the U.S. Food and Drug Administration (FDA), the manufacturer—Western Enterprises—voluntarily recalled various OxyTOTE Portable Oxygen System regulators (OxyTOTE, OxyTOTE 3000, OxyTOTE NG, OxyTOTE 3000 NG) due to the potential for the compressed gas oxygen cylinders to ignite and explode. The recalled devices are used to deliver prescribed flow rates of oxygen to patients. All lot numbers are affected by the recall. The recall was deemed a Class 1, which is the FDA’s most serious recall status. Class 1 recalls are reserved for situations in which exposure to a recalled product—in this case, Western Enterprises’ Oxytote Oxygen System regulators—may present a risk for serious injury or death.

Parker Waichman comments that the Class 1 designation was certainly warranted in this case, given the recalled oxygen system regulators’ risk of ignition and explosion. According to Parker Waichman, being aware of medical device recalls and potential defects may help decrease the likelihood of patient injuries. “As a firm that has represented numerous individuals in lawsuits brought over injuries that are associated with drugs or medical devices, Parker Waichman has seen, firsthand, the dangers associated with exposure to defective medical products,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “The firm strives to ensure consumers are kept up-to-date with the current medical device and drug recall information and potential complications.”

Parker Waichman offers free legal consultations to victims who have suffered adverse health effects as a result of defective medical devices. Please contact the firm for a free case evaluation by visiting or calling 1-800-LAW-INFO (1-800-529-4636).

Release ID: 88402