Draeger’s SafeStar 55 breathing system filter (model number MP01790), distributed between Aug. 18, 2021, and Oct. 12, 2021, is the affected product.
The company initiated the recall on May 9, 2022, and has recalled 35,950 total devices in the U.S. to date. According to the FDA notice, there has been one complaint and one injury associated with use of the device with no reported deaths.
Draeger’s SafeStar 55 comprises part of a ventilator for use when a patient is under anesthesia or needs breathing assistance. It is designed to reduce contaminants such as bacteria, other micro-organisms and small particles that reach a patient who is receiving breathing support from the ventilator.
The company recalled the specific LT2103 lot of the…