Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00834-1
Product Name/Description PhaSeal Secondary Set (C61)

Product code: 515302

Lot Number: 1005467

Distributed between 3/11/17 - 23/04/18

ARTG Number: 299777
(Becton Dickinson Pty Ltd - Basic intravenous administration set)
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 25/06/2018
Responsible Entity Becton Dickinson Pty Ltd
Reason/Issue Becton Dickinson (BD) has received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.

This defect was noted by customers during product use. Leakage was observed between the connector to the Secondary set spike and the tubing to the spike joint. The defect cannot be detected by visual inspection only.

8 reports relating to this issue have been received in Australia. To date, no reports of injury have been received in Australia.
Recall Action Recall
Recall Action Instructions BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.

This action has been closed out on the 16/10/2018.
Contact Information 1800 833 372 - BD Customer Service