Some of the devices may have a gasket leak which would interrupt or provide inadequate patient anesthesia and ventilation. Temporary or permanent injury or death could occur as a result. A gasket leak would also endanger operating room personnel with exposure to leaking anesthesia gases.
The affected devices were manufactured between May 2011 and March 2012 and distributed between May 31, 2011 and July 15, 2012.
Facilities should consider having a backup mechanism for maintaining patient ventilation in the event of a device recall.
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