Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used
Summary
The FDA issued a Class I for Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; by Vyaire Medical, Inc.. Reason: Potential of the nozzle separating during patient use..
Details
Source
Device Recall
External ID
Z-1730-2024
Action Date
2024-05-15
Status
Ongoing
Category
device
Product Description
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
Lot/Code Info: UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Quantity Affected: 649 devices
Reason for Recall
Potential of the nozzle separating during patient use.
Distribution
US nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Hochberg, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 151 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Vyaire Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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, Inc.) 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, Inc. have FDA actions?
Vyaire Medical, Inc. has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1730-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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