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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00736-1
Product Name/Description	Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit Catalogue Number: 99424 Batch Number: 201552 ARTG Number: 226699
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/06/2016
Responsible Entity	Teleflex Medical Australia Pty Ltd
Reason/Issue	Teleflex is recalling the Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit, as the kit was found to contain an incorrect component. The kit should be packaged with a 50mm guedel airway. However, a twin port mask was packed in the kit instead. If a 50mm guedel airway is missing from the package, this may result in a delay of treatment/airway irritation due to sub-optimal size/compromised airway. Given the patient population associated with the use of this device, a delay in resuscitation has the potential to lead to adverse health consequences.
Recall Action	Recall
Recall Action Instructions	Users are notified that on receipt of the acknowledgement form a return goods authorisation number will be issued and then a member of the Teleflex team will arrange collection of any affected stock from each facility. A credit will be applied to the customer account for stock returned as part of this recall. This action has been closed-out on 15/02/2017.
Contact Information	1300 360 226 - Teleflex Medical Australia Customer Service