Draeger Medical Recalls Breathing Therapy Equipment Due to Manufacturing Defects, Posing Serious Health Risks
Draeger Medical has initiated a recall of a positive airway pressure system and breathing circuit specifically designed for infant breathing therapy during hospitalization.
The recall is attributed to a manufacturing defect affecting the Seattle-Positive Airway Pressure Plus device and breathing circuit, as well as anesthesia kits. During manufacturing, a problem arose with the glued connections in the hose, leading to potential loosening. This issue can result in partial or complete detachment of the hose connector, jeopardizing oxygen supply and potentially causing oxygen deprivation or even fatalities.
The U.S. Food and Drug Administration has classified this recall as Class 1, indicating the highest risk category for severe injuries or fatalities if the affected devices are used. As of now, no injuries or deaths associated with these devices have been reported.
Over 500,000 Devices Affected by the Recall
Draeger Medical has recalled a total of 570,459 units of the affected devices across the United States. These devices were distributed between January 1, 2019, and February 28, 2023, and were sold under various product names, including:
- Anesthesia Circuit Kit Coax HEPA
- Seattle PAP Plus
- VentStar Basic
- VentStar Coax
- VentStar Watertrap
Draeger Medical has sent an urgent medical device recall letter to notify customers about the potential hazards posed by these products. A complete list of the recalled items can be found on the FDA’s website.
Individuals affected by the recall should immediately discontinue the use of these devices and seek alternative therapy options. To arrange for the replacement or return of unused products, customers can contact Draeger via phone at 1-800-437-2437 (available from 8 a.m. to 6 p.m.) or through email at US-Medical@draeger.com.
Philips CPAP Recall and Potential Health Risks
It’s worth noting that similar issues with manufacturing have also been observed in devices intended for adult use. In a significant recall conducted by Philips Respironics in 2021, over a million CPAP machines used to treat sleep apnea were affected, leading to numerous Philips CPAP lawsuits.
As of June 2023, the FDA has reported an increase in the total number of affected individuals due to the recalls. An additional 40 deaths and 6,000 complaints were added, covering the first three months of 2023. This brings the cumulative figures to more than 105,000 potential issues and 385 reported deaths. Both the FDA and Philips emphasize the need for further investigation into these newly reported complaints.
The recalls were prompted by the discovery of a breakdown in polyester-based polyurethane foam (PE-PUR), utilized to control sound and vibration in certain devices. The degradation of this material can lead to the release of toxic particles and gases that may be inhaled or ingested by users.
In addition, the FDA has received reports of potential side effects associated with the use of the recalled devices, including asthma, chest pain, lung disease, organ damage, pneumonia, and respiratory failure. Several cases of various cancers linked to exposure to the foam in the machines have also been reported to the FDA. Philips, on the other hand, stated in June 2022 that the foam’s chemical emissions should not pose health problems.
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