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U.S. Department of Health and Human Services

Class 1 Device Recall Vyaire

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 Class 1 Device Recall Vyairesee related information
Date Initiated by FirmApril 08, 2024
Date PostedMay 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1730-2024
Recall Event ID 94256
510(K)NumberK150810 
Product Classification Calculator, pulmonary function data - Product Code BZC
ProductVyaire 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.
Code Information UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Recalling Firm/
Manufacturer		 Vyaire Medical, Inc.
Leibnizstr. 7
Hochberg Germany
For Additional Information ContactJared Cardon
49 931 4972 400
Manufacturer Reason
for Recall		Potential of the nozzle separating during patient use.
FDA Determined
Cause 2		Process control
ActionVyaire Medical issued an URGENT Field Safety Notice to its consignees on 04/08/2024 via email. The notice explained the issue, requested a pull out test for all affected devices to verify the adhesive is adequate prior to use. If the product was further distributed, the party distributing device was directed to notify those to whom the device was sent. For any additional questions or concerns, please contact Vyaire at GMBEMEA- FSCA-RDX-INTL@Vyaire.com.
Quantity in Commerce649 devices
DistributionUS nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BZC
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