| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00161-1 |
| Product Name/Description |
BD Q-Syte Luer Access Split Septum Device
(Connector designed to allow access to injection sites for delivery of medication)
Catalogue Number: 385100
Lot Number: 4128925
ARTG Number: 96767 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some units have an off-centred slit in the silicon septum resulting in a thinner column wall. When actuated, units with a thinner column wall may tear leading to leakage of infusate/medication or blood from the side vent opening. In addition to leakage, the manufacturer has identified that there is a small
potential risk for air to enter the bloodstream which could result in air embolism. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to discontinue use of and immediately quarantine any of the affected stock. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 656 100 - Becton Dickinson Customer Service Department |