Draeger 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.
If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient. That lack of oxygen (hypoxia) 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.
The Draeger SafeStar 55 is a breathing system filter that is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance. 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.
On May 16, 2022, Draeger issued an Urgent Medical Device Recall letter to customers who may have received filters from the affected lot.
The letter requested customers check stock for filters with the lot number LT2103, segregate/quarantine any filters with the lot number listed, contact the company to replace affected filters free of charge and to receive pre-paid shipping to return affected filters, notify any other affected parties about this issue, including third parties who may have received this device, and return a Customer Acknowledgement form to confirm receipt of the information and that stock has been checked.