| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00131-1 |
| Product Name/Description |
ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP
Item Numbers: 0306573000, 0210114100
Lot Numbers: 17282012, 17283012
ARTG Numbers: 139627 and 141176 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
During routine testing, it was found that bioburden levels of the manufacturing process were higher than internal acceptable rates and as such the sterility of the products cannot be confirmed.
To date there have been no reports of any adverse events or serious injuries. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising customers immediately quarantine the product and return it back to Stryker. A Stryker representative can help facilitate this return where necessary.
This action has been closed out on the 13/12/2018. |
| Contact Information |
02 9467 1175 - Stryker Customer Service Support |