| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00145-1 |
| Product Name/Description |
AnastoClip AC Closure System
Catalogue Number: 4012-02
Lot Numbers: EAV1023 (Expiry Dec. 2020), EAV1032 (Expiry Sept. 2021)
Catalogue Number: 4012-03
Lot Number: EAV1016 (Expiry 28 Oct. 2020)
ARTG Number: 120976 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, LeMaitre Vascular has identified that the box labels for certain lots of catalogue numbers 4012-02 and 4012-03 have an incorrect dimension listed. The box label for each size device illustrates a clip gap that is smaller by 0.3mm – 0.5mm than the actual clip of each size product. The IFU and Tyvek labels for the product have the correct size of the clip gap noted for each size. There have been no complaints about this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is advising customers that all affected product should be returned for replacement. This action has been closed-out on 06/07/2017. |
| Contact Information |
02 9006 1662 - Emergo Australia |