| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00408-1 |
| Product Name/Description |
ARROW PICC Kits with Peel-Away Sheath Component
Catalogue Numbers: PI-01351-LS, PI-01351-SS, PI-01451-LS, PI-01451-SS, PI-01552-LS, PI-01552-SS, PR-05041, PR-05041-T, PR-05042, PR-05052, PR-05052-MW
Multiple Lot Numbers
ARTG Numbers: 148783 and 148784 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Arrow International has received complaints related to peel away sheath flare for the Arrow PICC kits. The instructions for use included with the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. The use of a skin nick reduces the possibility of sheath flare and subsequent complications. There is a remote possibility the device may cause a delay in treatment or minor damage to the vessel wall or subcutaneous tissue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Teleflex is advising users that they may be required to use an alternate enlargement method or perform a skin nick for difficult insertions. Customers are also requested to include the supplementary card (Product Notice) with their affected stock.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |