| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00734-1 |
| Product Name/Description |
NeoMed Enteral Feeding Tubes with EO Connectors
Multiple Model and Lot Numbers
ARTG Number: 236074
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Tube, feeding, nasoenteral) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. The tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. As described in the Instructions for Use (IFU) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. To date, no adverse events related to this issue have been reported to NeoMed. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given in the Customer Letter.
This action has been closed out on the 16/10/2018. |
| Contact Information |
02 9006 1662 - Emergo |