| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00480-1 |
| Product Name/Description |
Per-Q-Cath PICCs
ARTG Number: 145471 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
During an internal labelling review, Bard identified that the product gauge size (Ga) is incorrect on certain Per-Q-Cath products. The product gauge (Ga) size is provided in two locations: on the label and in some cases on the catheter hub. This issue has been identified as a conversion problem (French to Gauge size). No adverse reaction reports or other indication of injuries or diseases have been reported relating to this problem |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is providing the correct Gauge measurement to hospitals and healthcare professionals. This action has been closed-out on 04/08/2016. |
| Contact Information |
02 8875 4000 BARD Australia |