Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from
Summary
The FDA issued a Class II for Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used by Dynasthetics LLC. Reason: Due to a manufacturing issue that may result in filter leakage..
Details
Source
Device Recall
External ID
Z-1591-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P
Quantity Affected: 28 filters
Reason for Recall
Due to a manufacturing issue that may result in filter leakage.
Distribution
U.S.: N/A O.U.S.: Australia
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-09
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Dynasthetics LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dynasthetics LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dynasthetics LLC have FDA actions?
Dynasthetics LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1591-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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