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Draeger, Inc Recalls Defective SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow to Patients

Draeger, Inc is recalling a specific lot (LT2103) of the SafeStar 55 Breathing System Filter because of defective filters, including some that may be partially obstructed, were inadvertently distributed. If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient including a patient receiving anesthesia.  

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Questions?

Customers with questions or concerns about this recall should contact Michael Kelhart at Draeger, Inc between the hours of 8:00 AM – 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).