| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00986-1 |
| Product Name/Description |
ARROW Pressure Injectable PICC Kit
Product Code: PR-35041-HPHNM
Lot Numbers: 13F16A0089, 13F16A0180, 13F17B0290
ARTG Number: 278735 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
7/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
As a precaution, Arrow International has initiated a recall for this product because these finished good kits may potentially contain an incorrect component. This issue came to light through an internal inspection.
A 4Fr single lumen catheter was found in a 5Fr double lumen kit. Through investigation at the manufacturing facility it was determined that there is a potential that the reverse scenario could also have occurred, 5Fr double lumen catheter ending up in a 4Fr kit thus both product codes/lots are in scope of the action.
Zero complaints have been received for this issue (either scenario) furthermore no product has been found internally for 5Fr catheter in a 4Fr kit. |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex is requesting that customers:
1. Provide the customer letter to all who need to be aware of it within their organisation.
2. Inspect any stock on hand. The kit tray is transparent & does not need to be opened to determine the type of included catheter.
3. Lift the non-sterile pouch with the product information up to identify if the catheter has a single or double lumen.
4. Once all stock has been inspected, complete the Acknowledgement Form supplied with the customer letter with the details obtained during inspection. Note - include details of all stock implicated in this issue.
5. Return the completed & signed form to austcs@teleflex.com by 1 September 2017. If stock contains a 4FR Single lumen catheter – there is no impact and the stock can be used as normal. If stock contains a 5FR Double lumen catheter – this stock is impacted. In the event you have impacted stock a customer service team member will be in contact with you to arrange collection of the goods.
This action has been closed out on 15/10/2018 |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |