The FDA has issued a Class I recall for multiple anesthesia breathing circuit kits due to cracks in the hose that could cause inadequate ventilation.
The affected products include VentStar 220 as well as Anesthesia Circuit Kit Flex 1, 2, 6, (P)2 and HEPA, according to a June 5 news release from the FDA.
The products are typically used in hospitals and clinical settings to deliver breathing gases to patients who are under anesthesia or during medical ventilation.
Draeger, the device manufacturer, sent an urgent medical device notification to all affected customers March 3.
Using the affected products may lead to serious health consequences such as low oxygen levels, high carbon dioxide levels and death. Draeger has not reported any serious injuries or death related to the issue, the release said.
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