Neonate Resuscitator with Coded Airway & Filter Resuscitator Kit 의 리콜

Recall

RC-2016-RN-00736-1

Class II

2016-06-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00736-1

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.

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.