Monnal T60 Ventilator (2019-09-30)

Starting date:

September 30, 2019

Posting date:

October 18, 2019

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-71309

Last updated: 2019-10-18

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  Reason
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  Affected products

Affected Products

Monnal T60 Ventilator

Reason

2 Issues being addressed:

1. Early hardening of the silicon membrane after the sterilization cycle which is dependent on the disinfectant solution used during the immersion process. This change in the characteristics of the silicon membrane could have an impact on the ventilation. 

2. Air Liquide Medical Systems wishes to better specify the need for filters both to protect the integrity of the device and to prevent cross-contamination.

Affected products