| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00466-1 |
| Product Name/Description |
CADD Infusion System Infusion Sets
List Numbers: 21-7300-24, 21-7309-24, 21-7322-24, 21-7323-24, 21-7359-24, 21-7391-24, 21-7394-24
Multiple product descriptions and Batch numbers
ARTG's: 397091 & 400443 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical has identified additional lots of CADD Infusion System Infusion Sets that are potentially affected as detailed in the previous action of RC-2023-RN-00529-1 for problem 1.
Problem 1: Manufacturing variations may cause the green CADD Flow Stop arm to compress and partially occlude the tubing before clinical use. This may result in under delivery, despite the pump displaying that the infusion is running properly. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smiths Medical are advising pharmacists, clinicians and patients to use alternate CADD infusion sets for life sustaining medications.
Smiths Medical will replace impacted stock. Impacted stock should be returned for credit.
This action has been finalised on 20/8/2024. |
| Contact Information |
1800 654 949 - Customer Service |