| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00681-1 |
| Product Name/Description |
T34 Ambulatory Syringe Pumps
Catalogue Numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS
All Pump Serial Numbers
ARTG Number; 131232
(REM Systems - Infusion pump, syringe) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that there can be a 2mm +/- overall length difference between various manufacturers PP3 batteries that could be used in NIKI T34 Ambulatory Syringe Pumps.
This could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed in the Customer letter
This action has been closed out on 05/04/2022 |
| Contact Information |
1800 737 222 - REM Systems |