| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00052-1 |
| Product Name/Description |
MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System
Item Numbers: 6630, 9951, 9952
Multiple Lot Numbers
ARTG Numbers: 258033, 264273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
A report has been received indicating that the outer label of a MEDPOR Sizer Set states ‘sterile’, whereas the product is actually delivered non-sterile. Investigations have revealed that additional products and lots have an incorrect sterility status on their labels. The introduction of a non-sterile device into the sterile surgery field could potentially cause infection requiring additional medical or surgical treatment. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect their inventory and quarantine affected stock. They are requested to contact Stryker to coordinate the return of affected products for a resupply or a credit. This action has been closed out on 16 June 2017. |
| Contact Information |
02 9467 1175 - Stryker |