Recall Z-1591-2023— Dynasthetics LLC
Class II · Ongoing
Class II FDA medical device recall by Dynasthetics LLC, initiated 2022-05-09. It names one FDA 510(k) clearance: K092031. 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: Due to a manufacturing issue that may result in filter leakage..
- Recalling firm
- Dynasthetics LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-09
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.