| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00435-1 |
| Product Name/Description |
Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256
Multiple Material Numbers
ARTG Number: 206768
(Getinge Australia - Catheter, intravascular, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
An Arterial Cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula.
The vent plug of our Arterial Cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. After the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit.
Getinge has been made aware that in some instances, the vent plug can break during the separation from the Arterial Cannula. |
| Recall Action |
Recall |
| Recall Action Instructions |
Getinge is advising customers to immediately return affected product to their local Getinge representative.
Due to the discontinuation of the Surgical Perfusion Catheters/Cannulae product portfolio, Getinge are not providing replacement.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 438 464 - Getinge Customer Service |