Z-1591-2023 Class II Ongoing

Recalled by Dynasthetics LLC — Salt Lake City, UT

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