| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01006-1 |
| Product Name/Description |
70mL Centrifuge Bowl
Cell Saver 5/5+ Bowl Set - 70mL
Product ID: 0291E-00
Cell Saver Elite Processing Set - 70mL
Product ID: CSE-P-70
Cell saver 5/5+ Bowl Set - 70mL
Product ID: 0291A-00
ARTG Number: 123999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
A leaking bowl may potentially expose the operator to blood. In addition, because some amount of autologous blood intended to be returned to the patient would not be available for return, an allogenic blood transfusion may be required. |
| Recall Action |
Recall |
| Recall Action Instructions |
Haemonetics is requesting customers:
1. Discontinue use of the affected products; and
2. Return any unused product to Haemonetics
Contact your local customer service representative to coordinate the return, shipment and credit receipt of unused product.
This action has been closed out on the 11/10/2018. |
| Contact Information |
1800 209 515 - Haemonetics Customer Service |