Health product recall

Monnal Eva Expiratory Valve, Single use & Expiratory Flow Sensor, Single use (2020-03-29)

Starting date:
March 29, 2020
Posting date:
May 8, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73027

Last updated: 2020-06-15

Affected Products

  1. Monnal Eva Expiratory Valve, Single use
  2. Expiratory Flow Sensor, Single use

Reason

These specific measures linked to the current outbreak for the care of Covid-19 patients are based on the growing demand for supply of Monnal Eva UU Expiratory sets and also for the membranes (KY665300) used with the Monnal Eva Expiratory Valve autoclavable version.

To ensure continuity of the care pathway during this ramp up of production, and better protect the final user against Covid 19, Air Liquide Medical Systems :

  • authorizes  by temporary derogation the disinfection of the Monnal Eva UU Expiratory sets and membranes (5 cycles)
  • recommends to add a hydrophobic filter before the expiratory sets.

Affected products

A. Monnal Eva Expiratory Valve, Single use

Lot or serial number
  • All codes
Model or catalog number
  • KY694800
  • KY694900
Companies
Manufacturer
Air Liquide Medical Systems
6 Rue Georges Besse, Parc de Haute Technologie
Antony
92182
FRANCE

B. Expiratory Flow Sensor, Single use

Lot or serial number
  • All codes
Model or catalog number
  • KY664500
  • KY664600
Companies
Manufacturer
Air Liquide Medical Systems
6 Rue Georges Besse, Parc de Haute Technologie
Antony
92182
FRANCE