| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00053-1 |
| Product Name/Description |
Moog Infusion System Administration Sets
340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE
340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE
Multiple Part and Lot Numbers
ARTG Number: 225965
(Fresenius Kabi Australia Pty Limited - Infusion administration set, infusion pump) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Fresenius Kabi Australia has received notice from the Manufacturer, Moog Medical Group, that they have initiated a Recall in the USA for certain non-filtered Moog IV Administration Sets manufactured between 9th June 2015 and 6th July 2016.
The Manufacturer received 7 complaints regarding particulate found on the tip of non-filtered Moog IV spike sets manufactured between 9th June 2015 and 6th July 2016. During that period, 1,390,720 non-filtered spike administration sets were manufactured. When found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. Introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. No complaints have been received in Australia to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1300 361 004 - Fresenius Kabi Australia |