According to a recall announcement published on fda.gov, Draeger, Inc is recalling its SafeStar 55 Breathing System Filter due to potentially deadly oxygen flow issues. The U.S. Food and Drug Administration identified the recall as a Class I recall, the most severe type of recall because the product can cause serious injuries or death.
The recalled SafeStar 55 Breathing System Filter has a model number of MP01790. The lot number is LT2103. This recall affects 35,950 units sold in the United States from August 18, 2021, through October 12, 2021.
SafeStar 55 is a ventilator filter used in certain breathing systems and is used when patients go under general anesthesia or a patient requires breathing assistance. The SafeStar 55 Breathing System Filter is supposed to decrease contaminants such as micro-organisms, bacteria, and small particles that could reach a patient who is on ventilator breathing support.
The SafeStar 55 Breathing System Filter is being recalled because a manual inspection process conducted discovered some defective filters. Some of the filters were found to partially obstructed and were accidentally distributed instead of being destroyed. When a filter on a ventilator is obstructed, oxygen cannot not flow correctly to the patient. The lack of oxygen (hypoxia) can cause life-threatening injuries and/or brain damage.
So far, there has been one injury and no deaths associated with the use of the recalled SafeStar 55 Breathing System Filter. Health care professionals who use Draeger SafeStar55 Breathing System Filters should check stock for SafeStar 55 Breathing System Filters with the lot number LT2103 and quarantine those filters. Customers should also contact Draeger Customer Service to replace any recalled filters free of charge.
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