| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00792-1 |
| Product Name/Description |
TA-500 TRAUMA SET AIR GUARD & SA-200 STD SET AIR GUARD DISP
Description: Fluido Standard Set
REF number: 671200
DT Part Number: TSC-671200
Description: Fluido Trauma Set
REF Number: 671500
DT Part Number: TSC-671500
ARTG 377530
(Device Technologies Australia Pty Ltd - Radiation blood/fluid warmer intravenous set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Recent quality control testing revealed a proportion of the tested samples have a presence of elevated levels of non-toxic particulates in Fluido single use sets.
The elevated levels of particulates were present in quantities which exceed maximum allowable thresholds.
These particulates may enter the blood and fluid warming system and therefore may enter the patient’s bloodstream.
Potential hazards of IV particulate contamination include an inflammatory response, phlebitis, embolism & infection.
However, the extended priming instructions directly mitigate the potential presence of particulates in the device to below acceptable levels.
The manufacturer has not identified any complaints, or reports of injury or death associated with this problem to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Before IV fluid administration of Fluido Trauma sets (671500) and Standard sets (671200) customers are to follow the Extended Priming instructions as provided in Annex I of the customer letter.
The Extended Priming Instructions directly mitigate the potential presence of particulates in the device to below acceptable levels and serves as the corrective action for devices in the field. |
| Contact Information |
0434 185 435 - dnewey@device.com.au - Product Manager David Newey |