Disposable Hyperinflation System (2019-07-24)

Starting date:

July 24, 2019

Posting date:

August 2, 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-70617

Last updated: 2019-08-02

• Reason
• Affected products

Affected Products

Disposable Hyperinflation System

Reason

Hyperinflation system has been packaged with the manometer, which did not include the shelf life of the manometer. The root cause was determined to be that the shelf life of the manometer was moved from ifu to pouch labeling. During assembly, manometer is opened from the pouch and attached to the hyperinflation bag. However, accompanying packaging (plastic pouch) for the manometer is discarded. This results in a loss of shelf life information for the finished good.

Affected products