FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters

Editor's Note

The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance.

The recall was initiated because some defective filters, including some that may be partially obstructed, were inadvertently distributed instead of destroyed. If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient.

There has been one complaint, one injury, and no reported deaths associated with this device.

Distribution dates were August 18, 2021, to October 12, 2021.