| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00431-1 |
| Product Name/Description |
EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty catheter)
Product code: AB35W06120135 and AB35W06040080
Lot numbers: 9855406 and 9855291
ARTG number: 172929 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Covidien is conducting a recall of two production lots of the EverCross 0.035 PTA Balloon Catheter because of a product labelling error. Based on customer reports and Covidien's internal investigation, it has been identified that there is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labelling. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately discontinue the use of the affected device and segregate this product from other inventory for returning to Covidien |
| Contact Information |
02 9418 9611 - Covidien Pty Ltd |