FDA recall Z-1591-2023

Dynasthetics LLC · Class II · 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.

Reason for recall

Due to a manufacturing issue that may result in filter leakage.

Distribution

U.S.: N/A O.U.S.: Australia

Key facts

Status
Ongoing
Initiation date
2022-05-09
Report date
2023-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2023