· Published by Health Canada · Official notice
| Model or catalogue number | Affected products | Lot or serial number |
|---|---|---|
| PVL1HCCA | Volara System | All lots. |
| M08474 | Volara P.Circuit Kit | All lots. |
| M08085 | Volara P.Circuit Kit | All lots. |
| PVL1ACCA | Volara System | All lots. |
| M08473 | Volara P.Circuit Kit | All lots. |
Baxter Corporation is issuing an urgent medical device correction for Volara System patient circuits due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy.