The FDA issued a Class I recall for Accutron's Ultra PC% flowmeter after two complaints that the anesthesia instrument was flowing nitrous oxide gas without any oxygen gas, according to the American Society of Anesthesiologists.
The Ultra PC% is used to control the flow of gases in a nitrous oxide-oxygen sedation system, mostly during dental procedures. However, when not mixed with oxygen, nitrous oxide can lead to temporary and permanent brain damage or death when inhaled.
Accutron voluntarily recalled the product. Though two complaints have been received about the defect, no injuries have been reported. Healthcare and anesthesia providers should report adverse effects or side effects to the FDA's MedWatch Safety Information program.
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The Ultra PC% is used to control the flow of gases in a nitrous oxide-oxygen sedation system, mostly during dental procedures. However, when not mixed with oxygen, nitrous oxide can lead to temporary and permanent brain damage or death when inhaled.
Accutron voluntarily recalled the product. Though two complaints have been received about the defect, no injuries have been reported. Healthcare and anesthesia providers should report adverse effects or side effects to the FDA's MedWatch Safety Information program.
More Articles on Anesthesia:
Covidien Presents Respiratory Monitoring Study at ASA Meeting
Survey: 90% of Anesthesiologists Say Perioperative IT Will Drive OR Success
Dr. Ralph Lydic Earns ASA Excellence in Research Award