Explosion fears have prompted the FDA to warn facilities and consumers not to use one of OxySure Therapeutic’s portable emergency oxygen systems.
The FDA has received multiple complaints related to the use of OxySure Model 615, including insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising and exposure to chemicals. It adds that chemical reactions in the canisters could cause them to explode.
Although OxySure voluntarily recalled replacement cartridges for the model in June 2015, the agency has deemed this action ineffective, according to a safety alert issued last week.
The FDA issued a letter to OxySure in December 2015 requesting the firm identify corrective actions to ensure the product was not being used by customers. However, the agency says the company has failed to address the safety issues.
OxySure has distributed at least 1,000 units nationwide since June 2013, according to the FDA. OxySure says it is troubled by the “suddenness and timing” of the FDA’s safety notice, and continues to stand by its product.
One of a devicemaker’s biggest headaches is handling a recall. Noted recall management specialist Pamela Furman Forest can ease your fears in just 10 minutes with our eLearning program Recall Management for Devicemakers by teaching your employees all they need to know about dealing with device recalls.