| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00555-1 |
| Product Name/Description |
Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)
Product Code: 7812500
Lot Number: REVH0705
ARTG Number: 136492 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Bard Access Systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the Replacement Connector for Groshong NXT PICC (for use with Groshong NXT, 5 Fr. Dual-Lumen PICC). The case label for the specific lot incorrectly identified the connector colour as “white”. The connector is red and is correctly identified by the unit label as “red”. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017. |
| Contact Information |
02 8875 4039 - Bard Australia |