| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01238-1 |
| Product Name/Description |
Bard Max-Core Disposable Core Biopsy Instrument
Biopsy Gun Dispos MaxCore 14gx10cm
Product Code: MC1410
Lot Numbers: REBN2123, REBP1199 and REBP1807
Biopsy Gun Dispos MaxCore 16gx16cm
Product Code: MC1616
Lot Number: REBP1420
Biopsy Gun Dispos MaxCore 18gx16cm
Product Code: MC1816
Lot Number: REBN0342
Biopsy Gun Dispos MaxCore 18gx20cm
Product Code: MC1820
Lot Number: REBQ1014
ARTG Number: 180984 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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.
This action has been closed out on 27/02/2019 |
| Contact Information |
02 8875 4021 - Bard Australia |