Draeger SafeStar 55

2022: Recall of defective filters

On June 21, 2022, Draeger announced the recall of tens of thousands of defective Draeger SafeStar 55 respiratory filters. Filters are disposable accessories for a ventilator and can be used when the patient is undergoing anesthesia.

The U.S. Food and Drug Administration (FDA) has notified that the recall is Class I, the most critical. The Draeger SafeStar 55 Respiratory Filter has model number MP01790, distributed between August 18, 2021 and October 12, 2021, is a recall product.

Draeger SafeStar 55 Respiratory Filter

Draeger began the recall on May 9, 2022 and withdrew 35,950 filters in the United States as of June 21, 2022. According to the FDA notice, one complaint and one injury were reported in connection with the use of defective filters, with no deaths reported.

Draeger SafeStar 55 is designed to reduce contaminants such as bacteria, other microorganisms, and small particles that reach a patient receiving breathing support from a ventilator or inhalation anesthesia machine. The company recalled a specific batch (LT2103) of filters because as a result of the manual inspection process, some defective filters, including those that may be partially blocked, were accidentally passed on to customers instead of being destroyed.

In the event that the filter on the ventilator or respiratory system is clogged, oxygen or oxygen-air mixture cannot flow to the patient properly, and the resulting potential lack of oxygen (hypoxia) can lead to serious consequences, including death. In this case, in the event of such a dangerous situation, the IVL apparatus or the anesthesia-respiratory apparatus will give an appropriate alarm signal. Draeger issued an urgent letter recalling medical equipment for customers who may be affected on May 16, 2022. The letter asked customers to check for filters with the LT2103 lot number, separate/quarantine any filters from this lot and contact the company for free replacement of affected filters and receive prepaid delivery to return affected filters.^[1]

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