| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00124-1 |
| Product Name/Description |
Terumo CVS CDI H/S Cuvette provided within the Medtronic Perfusion Tubing Pack
Model Numbers: M612501C, CB7W53R1, CB7P87R9 and M613301A
Lot Numbers: 210283502, 210370420, 210370463 and 210545011
ARTG Number: 232954 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that when using an affected CDI H/S Cuvette in the CDI Blood Parameter Monitoring System 500, it may not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is providing users with additional instructions to ensure the Cuvette is connected prior to surgery. If the cuvette cannot be properly seated, alternative methods of blood gas monitoring should be performed. |
| Contact Information |
02 9857 9000 - Medtronic |