FDA issues ‘most serious type of recall’ over breathing system filters that could cause death

It’s a Class I recall that health care workers need to know about

The U.S. Food and Drug Administration (FDA) has issued a recall for 35,950 units of Draeger, Inc. SafeStar 55 Breathing System filters for possible obstructions that may block oxygen flow. “The FDA has identified this as a Class I recall, the most serious type of recall,” a letter published by the FDA said. “Use of these devices may cause serious injuries or death.”

The filter is used as part of a ventilator for patients under anesthesia or otherwise in need of breathing assistance and is intended to reduce contaminants such as bacteria, small particles and other micro-organisms.

According to the letter, an injury associated with the faulty device has been reported.

“If the filter on a ventilator or breathing system is obstructed, oxygen may not flow properly to the patient,” the letter said. “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 55 Breathing System filters affected have the product model number MP01790, are part of lot number LT2103 and were distributed between August 18, 2021 and October 12, 2021.

Draeger issued an Urgent Medical Device Recall letter on May 16 to customers who may have received filters from the affected lot.

The company is asking health care customers to check their stocks for filters with the lot number LT2103 and to quarantine any filters with the listed number. Affected customers can contact Draeger customer service at 1-800-437-2437 or email US-Medical@draeger.com to have their faulty filters replaced free of charge.

The company is also asking affected customers to notify other affected parties about the issue. Anyone with questions or concerns about the recall can contact Draeger quality manager Michael Kelhart at 1-800-437-2437 (press 1 at the prompt, then 32349).

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