| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01597-1 |
| Product Name/Description |
BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venous
Description:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PG
Item Number: H965458830
Catalogue Reference: 45-883
Lot Number: 4908978
Expiry: 30 June 2017
ARTG Number: 203831 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Navilyst Medical, Inc., the manufacturer of the BioFlo PICC with PASV Valve Technology, is conducting a recall based on information received from Greatbatch Medical, who manufacturers the ViaPeel PTFE Peelable Introducer. Navilyst Medical has confirmed that the affected sheaths from a Greatbatch Medical Recall of the Peelable Introducers (Greatbatch Model Number 10890-006) have been included in packaged BioFlo PICC Kits. These particular Introducers have the potential for the handles to detach from the sheath during use. This may result in user dissatisfaction and/or prolonged procedure, or if both handles detach, the sheath tube could migrate into the patient leading to an unplanned surgical retrieval.. Navilyst Medical has received several complaints from users, but to date, there have been no reports of patient injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is advising users to immediately stop using and quarantine the affected lot of Bioflo PICC Kits. Affected product is to be returned to the distributor Florey Medical Pty Ltd. Replacement product or credit will be issued via the distributor.
This action has been closed-out on 19/03/2018. |
| Contact Information |
08 8180 0640 - Florey Medical |