Recall Z-1730-2024 ยท BZC Calculator, Pulmonary Function Data
Vyaire Medical, Inc.
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.
| Date | May 8, 2024 (initiated Apr 8, 2024) |
| Status | Open, Classified |
| Reason | Potential of the nozzle separating during patient use. |
| Root cause | Process control |
| Action | Vyaire 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 | 649 devices |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150810 | Vyntus / SentrySuite Product Line Carefusion Germany 234 GmbH, Aug 14, 2015 |