The FDA today issued a notice confirming that a recall of ventilator filters from Draeger is Class I, the most serious kind.
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 SafeStar 55 breathing system filter because a manual inspection process led to some defective filters, including some that may be partially obstructed, being inadvertently distributed instead of destroyed.
If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient and the resulting potential lack of oxygen (hypoxia) can lead to serious effects, including death.
Draeger issued an urgent medical device recall letter to customers who may be affected on May 16, 2022. The letter requested that customers check for filters with the lot number LT2103, segregate/quarantine any filters from that lot and contact Draeger to replace affected filters free of charge and receive prepaid shipping to return affected filters.