| TGA Action ID |
RC-2020-RN-00589-1 |
| Type of Product |
Medicine |
| Product Name/Description |
0.9% Sodium Chloride bags 500mL and 1000mL
Product Code: K690521, K690531
Multiple Batch Numbers
ARTG
29745 (SODIUM CHLORIDE 0.9% 4.5g/500mL injection bag)
47400 (SODIUM CHLORIDE 0.9% 9g/1000mL injection bag) |
| ARTG Number |
29745 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Fresenius Kabi Australia received several complaints of Sodium Chloride 0.9 % bags of 500mL and 1000mL bursting when used in a pressure cuff for a prolonged period of time (long term).
The issue of bag burst is limited to when used under pressure cuff for an extended period of time (long term use). The bags are good for any other mode of infusion other than the use under pressure cuff. The container integrity is not affected, and the bags are suitable for transportation without any issue.
This issue may temporarily stop the patient treatment until the bag is changed which may result in delay to patient treatment and produce a spill hazard. In the worst-case scenario, the bags could burst in emergency/intensive care situations and affect patient treatment. |
| Instructions for Customers/Users |
Customers are advised that affected product can continue to be used when not put under pressure (pressure cuffed) settings.
For all customers that use the affected product under pressure cuff settings, Fresenius Kabi is advising to immediately identify any affected stock on site and quarantine. Fresenius Kabi will contact impacted customers to organise the return and replacement of all affected stock.
This action has been closed out on 03/06/2021 |
| Action Commencement Date |
6/07/2020 |
| Responsible Entity |
|
| Contact Information |
1300 361 004 - Fresenius Kabi Customer Service |