| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00508-1 |
| Product Name/Description |
WECK Visistat 35R Disposable Skin Stapler
Product Code: 528135
Lot Number: 73H1600207
ARTG Number: 126367 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
For a single product lot, Teleflex Medical has identified a labelling error on the boxes which contain six individually packaged and labelled device units. Some boxes are labelled as containing Visistat Wide devices, when they in fact contain Visistat Regular devices. The individual units are correctly labelled with the actual size of the device. The labelling error applies only to some units of sales boxes in the affected lot number. It is unlikely that the use of these products will result in any adverse health consequences, although it is possible there could be a delay of the procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Teleflex is advising users of the labelling error, and requesting that they place a copy of the customer letter detailing the issue with the affected lot.
This action has been closed out on 18/02/2019 |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |