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Anesthesia Breathing Circuit Correction: Draeger, Inc. Updates Instructions for Use for VentStar Flex and Anesthesia Circuit Kits Due to Cracks That May Lead to Inadequate Ventilation
The FDA is aware that Draeger, Inc. has updated the instructions for use for the VentStar Flex 220 and Anesthesia Circuit Kits Flex 1, 2, 6, (P)2 and HEPA due to a potential for cracks to form in the hose during use. These cracks may cause leaks, potentially resulting in the ventilator or anesthesia device providing inadequate ventilation. Possible serious adverse health consequences include low oxygen levels (hypoxia), high carbon dioxide levels (hypercarbia), and death. Draeger has not reported any serious injuries or deaths related to this issue.
On March 3, Draeger, Inc. sent all affected customers an Urgent Medical Device Notification recommending the following actions when using these breathing circuits:
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Use holders with a larger contact surface.
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Perform leak testing after stretching the flexible hose to the required length for the application.
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Inspect all inventory for affected products and ensure all device users in your facility are aware of the updated use instructions.
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Report any device malfunctions or adverse events to FDA MedWatch and Draeger Customer Service.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Draeger, Inc. Customer Service at (267) 664-1131.
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