| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01440-1 |
| Product Name/Description |
CADD Legacy 1, Model 6400 Ambulatory Infusion Pump
Product Number: 21-6400-51
Serial Numbers: 410006, 410007, 410008, 410009, 410010, 410011, 410012
ARTG Number: 109467 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical became aware that a number of CADD Legacy 1, Model 6400 Ambulatory Infusion Pumps, may contain non-matching serial numbers. Specifically, the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
The non-matching serial number issue does not impact the functionality of the Infusion Pumps. The risk to patient health as a result of this issue is negligible. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Smiths Medical is advising users to determine if the serial number on the back of the pump matches the electronic serial number programmed into the pump. If the serial numbers do not match, the pumps are to be returned to Smiths Medical.
This action has been closed out on 18/09/2018 |
| Contact Information |
1800 654 949 - Smiths Medical Customer Service |