| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00220-1 |
| Product Name/Description |
ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set
Catalogue Number: ADT1018
Lot Numbers: B151130E2 and B161115E0
Expiry: 30/11/2018 and 15/11/2019
Catalogue Number: ADT1018-40
Lot Numbers: B151130E2 and B161115E0
Expiry: 30/11/2018 and 15/11/2019
ARTG : 187558
(Emergo Asia Pacific T/a Emergo Australia - Flowmeter, blood, ultrasonic) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
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 sterilised; however, there is a small risk that unsterilised product may have been released. Given this possibility, in the event the ADT1018 Flow QC Tubing were to be used without being sterilised, this would increase the risk of infection post use for patients who have come into contact with any unsterilised product.
To date, no complaints or adverse events have been reported to Transonic related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
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.
This action has been closed out on 15/01/2019 |
| Contact Information |
02 9006 1662 - Emergo Australia |