CanadaHill‑Rom Services’ Volara System patient circuits and Volara P.Circuit Kit (all lots) — catalogue numbers M08473, M08085, M08474, PVL1ACCA and PVL1HCCA — are affected. Reports of air and medication leakage from the nebulizer cup can cause patient desaturation and ineffective nebulization. Contact the manufacturer for additional information.
What's being recalled
Companies: Hill-Rom Services Private Limited, 1 Yishun Avenue 7, Singapore, Singapore, 768923.
How to identify it
Affected products: Volara P.Circuit Kit; Lot or serial number: All lots.; Model or catalogue number: M08473
Affected products: Volara P.Circuit Kit; Lot or serial number: All lots.; Model or catalogue number: M08085
Affected products: Volara P.Circuit Kit; Lot or serial number: All lots.; Model or catalogue number: M08474
Affected products: Volara System; Lot or serial number: All lots.; Model or catalogue number: PVL1ACCA
Affected products: Volara System; Lot or serial number: All lots.; Model or catalogue number: PVL1HCCA
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)