| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01405-1 |
| Product Name/Description |
Bard ArcticSun ArticGel Pads
Item Code: 31700
Lot/Serial Numbers: NGAW3898 and NGBP1302
Item Code: 31705
Lot/Serial Numbers: NGAZ2312 and NGBN2492
Item Code: 31707
Lot/Serial Numbers: NGBN3536
ARTG Number: 262560 (Heating unit, pad, water) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Bard Medical Division (BMD), has identified specific lots of Bard ArcticSun ArticGel Pads that have insufficient adhesion of the hydrogel to the pad, which has the risk of the hydrogel peeling away from pads during the removal of the release liner. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is providing customers with additional instructions for use to identify the potential issue, and provide guidance to allow the product to be used in a normal manner.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
(02) 8875 4021 - Bard Australia |