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

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  Reason
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  Affected products

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