| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00446-1 |
| Product Name/Description |
BodyGuard Pump IV Administration Set
Catalogue Number: CE-GEN00014
Batch Numbers: 12387350 & 1483529
ARTG Number: 119624 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Caesarea Medical Electronics (CME) has identified that the SR segment in the sets from two batches have slight variations in dimensions, in some places being at borderline specification. These random variations along the tubing, when used in intermittent mode that includes long intervals of zero or near zero rate, may yield under- infusion results. |
| Recall Action |
Recall |
| Recall Action Instructions |
REM Systems is advising users to review their stock and quarantine the affected batches. Replacement stock will be provided by REM Systems.
This action has been closed out on 13/11/2018 |
| Contact Information |
1800 737 222 - REM Systems |