Z-1591-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- May 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 filters
Product Description
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.
Reason for Recall
Due to a manufacturing issue that may result in filter leakage.
Distribution Pattern
U.S.: N/A O.U.S.: Australia
Code Information
Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P