The Draeger SafeStar 55, a breathing system filter that is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance, has been identified by the U.S. FDA as a Class I recall, the most serious type of recall.
The SafeStar 55 Breathing System Filter is intended to reduce the contaminants like bacteria, other micro-organisms, and small particles, that reach a patient who is receiving breathing support from the ventilator. Use of these devices may cause serious injuries or death, the FDA says.
Approximately 35,950 devices—which were distributed between Aug. 18, 2021 to Oct. 12, 2021—have been recalled.
Draeger, Inc is recalling a specific lot (LT2103) of the SafeStar 55 Breathing System Filter because a manual inspection process led to some defective filters, including some that may be partially obstructed, to be inadvertently distributed instead of destroyed, the FDA says.
Earlier in May 2022, Draeger issued an Urgent Medical Device Recall letter to customers who may have received filters from the affected lot.
If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient. That lack of oxygen can have serious effects including death.
There has been one complaint and one injury associated with the use of this device. There have been no reported deaths.
Those affected by the recall include:
- Health care personnel who use Draeger SafeStar55 Breathing System Filters as part of a ventilator or breathing system for patients including patients receiving anesthesia
- People who receive breathing support or anesthesia using a ventilator or breathing system that includes Draeger SafeStar55 Breathing System Filters