The US Food and Drug Administration (FDA) issued a Class I product recall for the SafeStar 55 Breathing System Filter. The manufacturer, Germany based Draeger Inc, initiated the recall on May 9, following an injury and a complaint from its customers. A Class I recall is reserved for only the most serious of situations, for those products that may cause injury or death.
The issue was traced to a batch of defective filters that were distributed from August–October 2021. It was determined the filters were damaged during the manual inspection process. At that point, they were supposed to be destroyed, but were mistakenly sent out. All of the possibly affected filters are marked with a unique lot number, LT2103, so that customers who purchased the product between those dates can check if their filters may be damaged.
These filters attach to ventilators and help trap particles and microbes before they can get into patients’ lungs. However, this product flaw may block not only offensive particles, but oxygen flow. So obstruction by the filter would lead to hypoxia, which may lead to brain damage or death.
SafeStar is urging customers to check their product for the particular lot number. If they find they have received a defective batch, customers can have the filter replaced by Draeger by calling 800-437-2437 (press 2 at the prompt, then 1). They may also report these events to the FDA using the agency’s MedWatch website.