| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01075-1 |
| Product Name/Description |
BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap
Product Code: 0038460
Lot Numbers: NGZD0924, NGZD4923, NGZD3989, NGZD3241
Expiration dates range between April 30, 2020 and July 31, 2020
ARTG Number: 137628 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Bard Medical Division (BMD) has identified that certain product code / lot number combinations may be at risk for having a slit defect on the package which may affect product sterility. Use of a potentially non-sterile BARD Irrigation Syringe could introduce microorganisms which may lead to a varying degree of risk including localised and/or systemic infectious complications. In the event this occurred, the patient may require medical intervention. There have been no reports of patient injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bard is advising users that if affected product has been used, to monitor the patient for symptoms and signs of localised and/or systemic infection. Users are advised to inspect stock and quarantine any remaining units of the affected batches for return to Bard. This action has been closed-out on 03/03/2017. |
| Contact Information |
1800 257 232 - Bard Australia Customer Service |