Bard Max-Core Disposable Core Biopsy Instrument 의 리콜

Recall

RC-2015-RN-00330-1

Class I

2015-04-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00330-1

Bard peripheral vascular (bpv) has identified potential self-activation issues with the instrument during use that may pose an incremental increase in the risk associated with biopsy procedures. this includes prolonging the procedure, requiring the use of an additional device, or minor tissue injury to the patient if the device fails to fire. potential self-activation, may potentially lead to inadvertent injury to deep tissue or structures, blood vessels or adjacent critical organs. in addition, a used device may pose an incremental risk of blood borne contamination to the user if self-activated. in the event this occurred, the patient or user may require urgent medical or surgical intervention and the user is to follow facility procedures for inadvertent needle sticks or injury.

Bard Australia is requesting the customers to quarantine and stop using the affected product. Bard Australia is arranging for any affected product to be returned and replaced. This action has been closed-out on 1/06/2016.