Recall MonitorHealth Products
Microstream™ Advance Intubated CO2 Filter Line, VitaLine® Intubated CO2 FilterLine and FilterLine® Intubated CO2 Filter Line
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Microstream™ Advance Intubated CO2 Filter Line, VitaLine® Intubated CO2 FilterLine and FilterLine® Intubated CO2 Filter Line
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Filterline Set H Infant/Neonatal | Not applicable. | 9898031 60261 M1923A |
| Filterline Set Adult/Pediatric | Not applicable. | M1920A 9898031 60241 |
| Filterline Set H Adult/Pediatric | Not applicable. | M1921A 9898031 60251 |
| Filterline Set H Adult/Pediatric | Not applicable. | 9898031 59571 |
| Filterline Set H Infant/Neonatal | Not applicable. | 9898031 59581 |
Issue
The supplier of the Microstream™ Advance Intubated CO2 Filter Line, VitaLine® Intubated CO2 FilterLine and FilterLine® Intubated CO2 Filter Line has provided an update to the instructions for use (IFU) for affected product. The IFU addendum is being issued to address customer reports of difficulty or inability to disconnect an adapter from a patient's endotracheal tube in order to perform a procedure. The addendum includes information on potential adverse events that may result from a failure to follow instructions for safe use of the airway adapter, as originally stated in the IFU. Recall start date: April 15, 2025