CLASS II ONGOING Device recall · Reported 24 May 2023 · FDA Enforcement Report
Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended recalled
Dynasthetics is recalling Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to. The recall was initiated on 9 May 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1591-2023
- FDA event ID
- 92026
- Recalling firm
- Dynasthetics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 May 2022
- FDA classified
- 16 May 2023
- Reported
- 24 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 May 2022 | Recall initiated by company | |
| 16 May 2023 | Classified by FDA | +372 days |
| 24 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing issue that may result in filter leakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S.: N/A O.U.S.: Australia
Questions about this recall
Why was it recalled?
Due to a manufacturing issue that may result in filter leakage.
Which lots are affected?
Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Where was it sold?
U.S.: N/A O.U.S.: Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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