Recall Z-1591-2023 ยท CBN Apparatus, Gas-Scavenging
Dynasthetics LLC
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.
| Date | May 16, 2023 (initiated May 9, 2022) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue that may result in filter leakage. |
| 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 jorr@dynasthetics.com. |
| Quantity | 28 filters |
| Distribution | U.S.: N/A O.U.S.: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092031 | VAPOR-CLEAR, MODEL 100 Axon Medical, Inc., Apr 16, 2010 |