| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00465-1 |
| Product Name/Description |
Secondary Set Oncology
Catalogue Number: 72951NE
Lot Numbers: 1000089, 1000129, 1000208, 1000468, 1000469, 1000687 and 1000713
ARTG Number: 125916 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Becton Dickenson (BD) has received reports of cracking of the secondary set back check valve male luer resulting in leaking of the infusion fluid. During use of the set, a leak occurs at the connection between the needle free valve and Back Check valve (BCV) connection. Leakages can cause delay of infusion, interruption of infusion, exposure to infusates, or under-infusion. BD has not received any reports of serious injury or death associated with the separation or leaks. BD is not aware of any report of injury attributed to this defect in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
BD is advising users to discontinue use of and segregate the identified units, and then return to BD. Replacement stock or credit will be provided.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 833 372 - CareFusion Customer Service |