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) Item Code: ENCFINSERT10G 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