Vapor-Clean Anesthetic Filter Recalled Due to Manufacturing Leakage Defect
Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect that creates a risk of harm—potential leakage allowing anesthetic gases to reach patients. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation that meets the High severity threshold.
Plain-English summary
Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter, Part Number 111AU (Lot 0222P). This device is used in anesthesia delivery systems to remove unwanted anesthetic gases from the patient breathing circuit and is designed to prevent anesthetic vapors from the anesthesia machine from reaching patients.
The recall was issued due to a manufacturing issue that may result in filter leakage. If the filter leaks, unwanted anesthetic gases could bypass the filtration system and reach the patient during anesthesia delivery.
This device is distributed in Australia, with approximately 28 filters involved in the recall. Healthcare facilities and anesthesia professionals should discontinue use of affected units and contact Dynasthetics LLC for instructions on device replacement or return. No illnesses or injuries related to this defect have been reported to date.
The recalled product
- 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…
- Manufacturer
- Dynasthetics LLC
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Distribution
Distribution scope not specified by the agency.
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