Health product recall

SPUR II Adult Resuscitator with attached Inspiratory Filter (2019-04-16)

Starting date:
April 16, 2019
Posting date:
June 28, 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-70305

Last updated: 2019-06-28

Affected Products

SPUR II Adult Resuscitator with attached Inspiratory Filter

Reason

The SPUR II has been packaged with the GVS electrostatic filter accessory, which did not include the shelf life of the breathing filter. The root cause was determined to be that the shelf life of the GVS electrostatic filter is printed on the component packaging; however, during assembly the breathing filter is opened then attached to the SPUR II product but the accompanying packaging for the breathing filter is discarded. This results in a loss of shelf life information for the finished good.

Affected products

SPUR II Adult Resuscitator with attached Inspiratory Filter

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

520611033AF

Companies
Manufacturer
Ambu A/S
Baltorpbakken 13
Ballerup
2750
DENMARK