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.
FDA Recall Z-1591-2023 · Posted 2023-05-16
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Recalling FirmDynasthetics LLC
Recall StatusOpen, Classified
Product CodeCBN
Date Initiated2022-05-09
Product Quantity28 filters
Reason for Recall
Due to a manufacturing issue that may result in filter leakage.
Firm 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].
Root Cause
Employee error
Distribution Pattern
U.S.: N/A O.U.S.: Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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