Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01101-1
Product Name/Description Bard EnCor Needle Guide Insert (part of the EnCor Breast Biopsy Probe)


Multiple Lot numbers affected

ARTG Number: 153519
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/08/2016
Responsible Entity Bard Australia Pty Ltd
Reason/Issue Bard Peripheral Vascular has identified that the affected lot numbers may be at risk of having an incorrect EnCor Accessory Needle Guide Insert. Specifically, a smaller diameter (12G) insert may be contained within the larger (10G) package. This will render the device unusable and the user will need to replace the incorrect needle guide with one of the correct size. To date, Bard have received 6 complaints from customers that have received the smaller product in error; none have resulted in an adverse event to patient or loss of functionality of the EnCor Probe.
Recall Action Recall for Product Correction
Recall Action Instructions Bard is advising users that if the incorrect Needle Guide Insert is contained within the packaging, to utilise a new biopsy probe (12G) for the procedure. This action has been closed-out on 10/05/2017.
Contact Information 02 8875 4039 - Bard Australia