| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01222-2 |
| Product Name/Description |
Hypochlorite 1% Solution & Hypochlor 1% Solution
Product Codes: DL0403, HPH125 (1.25L) and DL0401 (500mL)
Batch Numbers: 2356 and 4209
Expiry Dates: 06/17 and 09/17
ARTG Number: 160242 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has come to Dentalife's attention that there is a contamination risk in two batches of sodium hypochlorite solution Small particles of black matter have been observed floating in several 1.25L bottles of the solution. The issue has been investigated and the material is suspected to be particles of a food grade grease used to lubricate the volumetric filling device as part of the manufacturing process. |
| Recall Action |
Recall |
| Recall Action Instructions |
Dentalife is advising users to discard affected stock for replacement. This action has been closed-out on 29/08/2016. |
| Contact Information |
03 9879 1226 |