Bard Max-Core Disposable Core Biopsy Instrument Biopsy Gun Dispos MaxCore 14gx10cm Biopsy Gun Dispos MaxCore 16gx16cm Biopsy Gun Dispos MaxCore 18gx16cm Biopsy Gun Dispos MaxCore 18gx20cm ARTG Number: 174371 의 리콜

Recall

RC-2017-RN-01238-1

Class I

2017-10-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01238-1

The manufacturer, bard peripheral vascular has identified that specific product code / lot number combinations may be at risk of having issues related to proper functioning of the device. this includes difficulty with priming and firing, failure to obtain tissue sample, and in some instances self-activating after priming.In most cases, the identified issues (failure to prime, failure to fire, failure to obtain a sample) will lead to a varying degree of user dissatisfaction or may be associated with a prolonged procedure or minor tissue injury. although unlikely to lead to user or patient injury consistent with a serious adverse event, the unpredictable nature of self-activation presents some risk to use of the product. there is no residual risk to users or patients that used the product previously without incident.

1. Bard is advising users to inspect stock and quarantine any remaining units of the affected batches. 2. Affected stock can be returned to Bard.