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U.S. Department of Health and Human Services

Class 2 Device Recall VaporClean

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  Class 2 Device Recall VaporClean see related information
Date Initiated by Firm May 09, 2022
Date Posted May 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-1591-2023
Recall Event ID 92026
510(K)Number K092031  
Product Classification Apparatus, gas-scavenging - Product Code CBN
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.
Code Information Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Recalling Firm/
Dynasthetics LLC
3487 W 2100 S Ste 300
Salt Lake City UT 84119-5863
For Additional Information Contact Joseph Orr, PhD
Manufacturer Reason
for Recall
Due to a manufacturing issue that may result in filter leakage.
FDA Determined
Cause 2
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 jorr@dynasthetics.com.
Quantity in Commerce 28 filters
Distribution U.S.: N/A O.U.S.: Australia
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBN and Original Applicant = AXON MEDICAL, INC.