| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00908-1 |
| Product Name/Description |
Isolator Synergy Clamps
Model number: EMR2
Lot number: 141594
ARTG 167710
(AA-Med Pty Ltd - Isolator Synergy Clamps - Lesion generator probe, radio-frequency) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
15/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
One lot of EMR2 product were manufactured without the included GPT100 glidepath tape. The GPT100 is listed as an accessory in the Instructions for Use (IFU-0119 revision B) that may be used to facilitate routing around cardiac structures. The GPT100 is packaged with the EMR2 device in the same, sterile packaging.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The distributor is to place the impacted product on hold and AtriCure will provide the GPT100 products. Once the replacement GTP100's are received the distributor is to attach them with the Isolator Synergy Clamp, to ensure end users receive all parts. |
| Contact Information |
0410 003 470 - Andrew Button, Area Director, Australia & New Zealand |