ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set 의 리콜

Recall

RC-2018-RN-00220-1

Class I

2018-03-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00220-1

Emergo has been notified by the manufacturer, transonic systems (transonic), that the sterility of adt1018 flow qc tubing set cannot be assured. transonic is not aware of any actual products that are not sterilized; however, there is a small risk that unsterilized product may have been released. given this possibility, in the event the adt1018 flow qc tubing were to be used without being sterilized, this would increase the risk of infection post use for patients who have come into contact with any unsterilized product. to date, no complaints or adverse events have been reported to transonic related to this issue.

Transonic has discontinued the ADT1018 product line and has ceased purchasing product from this supplier entirely. The ADT1010 tubing set replaces ADT1018 Flow QC tubing. Emergo is advising users to immediately discontinue use and distribution of the affected product. Return or destroy the affected product and document that destruction on the Medical Device Recall Return Response Form provided with the Customer Letter. Upon receipt of the completed form a product replacement will be issued. If it appears that any patients have had contact with the ADT1018 Flow QC tubing set, please observe these patients for any signs of infection as per your hospital protocol and report if any such events take place.