Health Canada posted a medical device safety alert concerning Invacare Precise RX Pediatric Flowmeter [Model numbers: IRCPF16, IRCPF16AW; Lot numbers: 16BF017557, 16CF030112, 16CF030121, 16CF032024, 16CF040071, 16CF040083, 16DF040094], manufactured by Invacare Corporation.
The manufacturer has identified that the rear gradation scale was screen printed upside down on the flowmeter gauge. Proper delivery of oxygen is critical to infants. In the population at greatest risk i.e. pediatric population, health impact specific to high oxygen saturation could result in systemic toxicity, potential lung vascular injury, or over extended period of time could cause blindness.
For details, please refer to the following Health Canada website:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/59460r-eng.php
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2016