| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00949-1 |
| Product Name/Description |
FMS Intermediary Tubing with One-Way Valve (used with FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy)
Product Code: 281142
Lot Number: D316810
ARTG Number : 149134 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing has identified that the one-way check valve (pillow valve) included in the FMS Outflow Tubing Set and the FMS Intermediary Tubing Set may occasionally not be performing as intended. If the instructions described in the FMS Duo System and Solo System Operator's Manuals are not followed, this may result in backflow of irrigation fluid into the "One Day" Set, and when used with affected tubing, could potentially lead to patient cross-contamination. Please note that the backflow of irrigation fluid can only occur if the check valve is not working properly and the pressure line is disconnected or the tension rocker is open. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to quarantine any affected stock and return it to JJM. Customers are also advised that when connected properly and used in accordance with the system’s Operating Manual, tubing with an affected check valve will not allow backflow of irrigation fluid into the One Day Set, and would not lead to potential patient cross-contamination. It is important to follow up with potentially affected patients per each institution’s Infectious Disease/Needle stick protocol. |
| Contact Information |
1300 562 711 - JJM Customer Service |