| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00635-1 |
| Product Name/Description |
HMC feeding, aspiration and feeding/aspiration tubes
All product codes beginning with: LG, NGP, NJP, RT, ST and EF2EL
ARTG 276654
(Intermed Medical Pty Ltd - Tube, feeding, nasoenteral) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Erasure of the graduation markings on tubes.
The problem was observed to be due to the use of incorrect cleaning and disinfection processes and excessive rubbing on the outer surface of the tubes. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The following indications are being added to the relevant Instructions for Use (IFU):
If necessary, clean the device with gentle movements avoiding excessive rubbing, and/or using neutral nonaggressive
detergents.
Updated IFUs will be made available with the next batches of manufactured products. |
| Contact Information |
1300 123 633 - Intermed |