Health product recall

Anaesthetic Masks (2019-08-12)

Starting date:
August 12, 2019
Posting date:
August 23, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70795

Last updated: 2019-08-23

Affected Products

Anaesthetic Masks

Reason

As a result of reports from the market we have identified a possible variation in the size of the 22F mask taper connection where some masks may be larger than standard limits. This may create a loose or insecure connection with the mating device, and in some circumstances this could result in possible disconnection from the mask taper. We would expect the problem to be identified during set up for use and to date there have been no reports of patient harm.

Affected products

Anaesthetic Masks

Lot or serial number

381956
383077
390394

Model or catalog number

1515000
1516000

Companies
Manufacturer
Intersurgical Ltd.
Crane House, Molly Millars Lane
Wokingham, Berkshire
RG41 2RZ
UNITED KINGDOM