Z-1591-2023Class II

Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic...

Name: Z-1591-2023 Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic...
Creator: Dynasthetics LLC
Published: 2022-05-09
License: https://open.fda.gov/license/

Dynasthetics / initiated 2022-05-09 / Open, Classified / root cause: manufacturing process

FDA source

Dynasthetics LLC began a recall of 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... on 2022-05-09. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue that may result in filter leakage". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1591-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-09
Posted: 2023-05-16
Recalling firm: Dynasthetics
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.
Product code: CBN Apparatus, Gas-Scavenging
Reason for recall: Due to a manufacturing issue that may result in filter leakage.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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].
Quantity in commerce: 28 filters
Distribution: U.S.: N/A O.U.S.: Australia
Product codes and lots: Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1591-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1591-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-16

Product code CBN

K092031Class IIVapor-Clear, Model 100Axon Medical, Inc. / cleared 2010-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)