Device product
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.
Z-1591-2023
Product summary
- Firm
- Dynasthetics LLC
- Event
- Event 92026
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 filters
- Official record key
device-enforcement:Z-1591-2023
Official wording
Reason: Due to a manufacturing issue that may result in filter leakage.
Code information: Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Distribution pattern: U.S.: N/A O.U.S.: Australia
Derived failure modes
-
Unknown
Due to a manufacturing issue that may result in filter leakage.