Vapor-Clean, Part Number 111AU recallZ-1591-2023 · Dynasthetics LLC · initiated May 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dynasthetics LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a manufacturing issue that may result in filter leakage.
FDA root cause category: Employee error
What the company is doing
On 5/9/2022, the firm was contacted by their O.U.S. customer regarding the issue with the use of Vapor-Clean filters and failure of pressure test on anesthetic machine. Through the firm's complaint investigation, Dynasthetics LLC was in communication with the customer and instructed the customer to destroy the affected product and to provided proof of destruction. After receiving proof of destruction, Dynasthetics would send replacement filters. For questions regarding this recall, contact Joseph Orr at 801-484-3820 or email [email protected].
Recall details
- Recall number
- Z-1591-2023
- Status
- Open, Classified
- Initiated by the company
- May 9, 2022
- Posted by the FDA
- May 16, 2023
- Recalling firm
- Dynasthetics LLC
- Quantity
- 28 filters
- Product code
- CBN
- FDA submissions
- K092031
- Distribution
- U.S.: N/A O.U.S.: Australia
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.
Code information (models, lots, serial numbers)
Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vapor Clean 10000Dynasthetics, LLC · Apparatus, Gas-Scavenging1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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