vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven
Summary
The FDA issued a Class II for vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with by Vyaire Medical. Reason: Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were.
Details
Source
Device Recall
External ID
Z-0489-2024
Action Date
2023-12-13
Status
Completed
Category
device
Product Description
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Lot/Code Info: UDI/DI 10190752155251: Lot/serial numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792
Quantity Affected: 16 circuits
Reason for Recall
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
Distribution
US: Florida
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-27
Company
Mettawa, IL
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 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vyaire Medical has 16 FDA actions in our database, including 16 recalls.
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 (Vyaire Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vyaire Medical have FDA actions?
Vyaire Medical has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0489-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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