FDA-Device2023-05-24Class II
Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
Dynasthetics LLC
Hazard
Due to a manufacturing issue that may result in filter leakage.
Sold states
U.S.: N/A O.U.S.: Australia
Affected count
28 filters
Manufactured in
3487 W 2100 S Ste 300, N/A, Salt Lake City, UT, United States
Products
Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2023Don't want to check this manually?
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