Australian Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff, manufactured by Covidien. The affected devices are identified as follows:-
The affected devices are identified as follow:-
The manufacturer is conducting this recall following reports from customers where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort immediately after the switch in a limited number of situations. In some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were observed immediately after the switch.
Serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall.
The manufacturer is requesting hospitals to discontinue use and quarantine all affected devices.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00412-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 May 2015