| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00719-1 |
| Product Name/Description |
Extension Set
(extension tubing for blood transfusion systems and standard intravenous administration sets)
REF 50.318H
Lot No. 20141226
ARTG Number 222156 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
BMDi TUTA Healthcare has been made aware of an issue with the female Luer lock (FLL) connector. When connected to the male luer lock (MLL) connector of another device the FLL may crack and subsequently leak. The reported incident rate is low and the fault has not been reproduced in house. |
| Recall Action |
Recall |
| Recall Action Instructions |
BMDi TUTA is requesting the customers to inspect, discontinue use, and quarantine affected stock for replacement. BMDi TUTA is arranging for the return of any remaining stock |
| Contact Information |
02 9466 5300 - BMDi TUTA |