| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00768-1 |
| Product Name/Description |
Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)
Catalogue number: IN01
Order code: NAAUIN01
Lot Numbers: 509029, 604025
ARTG number: 260068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Merck has received a product complaint regarding concerns of colour indications on packaging being insufficiently clear and the possibility of end users confusing the colour coding in the explanatory box with the corresponding colour on the pH strip.
Please note that with these pH indicator papers, the printed scale on the packaging serves purely as an instruction on how to use the product. The pH is only identified by comparison of the test square with the printed colours on the test strip itself. |
| Recall Action |
Recall |
| Recall Action Instructions |
Merck is advising users to inspect stock and remove any remaining strips of the affected lots from use. Affected stock will be replaced with a revised indicator strip or a credit note issued. This action has been closed-out on 20/02/2017. |
| Contact Information |
03 8727 6316 - Merck |