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.
Recall
- Recall Number
- Z-1591-2023
- Event Number
- 92026
- Firm
- Dynasthetics LLC
- FEI Number
- 3008776780
- Product Code
- CBN
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- May 9, 2022
- Posted
- May 16, 2023
- Address
- 3487 W 2100 S, Ste 300, Salt Lake City, UT, 84119-5863
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.
Due to a manufacturing issue that may result in filter leakage.
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].
U.S.: N/A O.U.S.: Australia
28 filters