| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00422-1 |
| Product Name/Description |
T4 Zipper Toga (XL - Tall) (Operating room gown)
Catalogue number: 0400850000
Lot numbers: Lots prior to 12040356
ARTG number: 141174 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Testing by Stryker indicated that the sterilisation barriers were not valid for the stated 3 year shelf life and a breach of sterilisation risk is present for products older than 2 years. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is asking customers to perform inspection of product expiry dates and lot numbers and discard any affected products. |
| Contact Information |
02 9467 1214 - Stryker Regulatory Affairs and Quality Assurance Coordinator |