| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00153-1 |
| Product Name/Description |
LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter
Product Codes: 9020413500150 and 9020515250040
Lot Numbers: GFXJ2800 and GFXK2769
Supplied under the Special Access Scheme |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Lutonix has confirmed that some devices from specific lots may have been packaged in foil pouches with a defective chevron seal. This is the seal used to open the package containing the sterile balloon catheter. The potential hazard associated with a package having a defective chevron seal is loss of sterility. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to not use or further distribute any of the affected product. Bard is advising that no special follow-up treatment or clinical care is recommended for patients who have already undergone treatment with the devices affected by this recall. |
| Contact Information |
1800 257 232 - Bard Australia Customer Service |