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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 Bard Australia Pty Ltd
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