| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01254-1 |
| Product Name/Description |
2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)
Distributed between June 2013 to June 2015
Multiple product and catalogue numbers affected
ARTG Number: 158417 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
BMD has identified that the Instructions For Use (IFU) included with the affected products provide the incorrect inflation volume. The inflation volume provided on the catheter’s valve cap does state the correct inflation volume. The IFU contains a chart entitled Recommended Inflation Volumes with incorrect volumes. The inflation volume provided on the catheters valve cap does state the correct inflation volume.
If the user follows the IFU and under inflates the balloon, the patient may experience some form of urine bypass due to the poor seating of the balloon in the bladder. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is providing users with the correct inflation volumes for the affected products. This action has been closed-out on 30/08/2016. |
| Contact Information |
02 8875 4012 - Bard Australia QA Department |