| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00561-1 |
| Product Name/Description |
Polyurethane Nasogastric Feeding Tube
Item Numbers: PH-05100PU, PH-06100PU, PH-06125PU, PH-08100PU PH-08125PU
Lot Numbers : 14004121, 13022911, 14004123, 13022912, 14004125, 13022915, 14004130, 13022913, 14004132 and 13022916
ARTG Number: 204612 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Pacific Hospital Supply Company, has determined that in certain lot numbers, after a number of times where routine folding of the tube occurs, the folding site has split which has resulted in leakage from the tube. The stretching during folding can produce a tensile (pulling) force which breaks the bonding between the two surfaces. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to immediately check their facility’s inventory for the affected lot numbers and quarantine any of the affected products. Await instructions from REM SYSTEMS Pty Ltd for the return and replacement of the affected product. This action has been closed-out on 02/02/2016. |
| Contact Information |
1800 737 222 - REM Systems Customer Service |