| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00770-1 |
| Product Name/Description |
Bard ArcticSun ArticGel Pads
Product Code: 317-07
Lot Number: NGAR0462
ARTG Number: 262560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Bard Medical Division (BMD) has confirmed that Lot NGAR0462 is incorrectly identified as 317-09 (large kit) rather than 317-07 (medium kit) on the product (shelf) box. Specifically, the shelf box has a black tick mark in the catalogue marked 317-09 instead of 317-07. The shelf box label with barcode and the pouch label is correctly identified as 317-07 and lot number NGAR0462. This mislabelling could potentially result in a slight delay in therapy but is not associated with long term or residual clinical consequences. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard Australia is requesting that following an inspection of stock on hand, customers should cross out the incorrectly marked line and tick the correct box “317-07”. The Recall for Product Correction does not require affected stock to be returned. Affected stock can remain on your shelves.
This action has been closed out on 18/09/2018 |
| Contact Information |
02 8875 4021 - Bard Australia |