PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: May 24, 2023 Initiated: May 9, 2022 #Z-1591-2023

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.

Details

Recalling Firm
Dynasthetics LLC
Units Affected
28 filters
Distribution
U.S.: N/A O.U.S.: Australia
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Dynasthetics LLC. Units affected: 28 filters.
Why was this product recalled?
Due to a manufacturing issue that may result in filter leakage.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1591-2023.