| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01290-1 |
| Product Name/Description |
Fenwal Transfer Pack 150ml with spike coupler (Blood collection/cell-culture container)
Catalogue / Order number: R4R2001
All batch numbers
ARTG Number: 169160 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Instruction for Use (IFU) manual for Fenwal Transfer Packs 150ml with spike coupler is updated to instruct the users of the proper technique to insert/remove the coupler in order to access the bag. Additionally a statement advising users that a suitable filter (170-200 microns) should be used when administering/transfusing blood products from this bag will also be added to the IFU. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Aurora Bio Science is arranging for recovery of affected stock, which is to be rectified with correct Instructions for Use (IFU). Replacement stock or a credit note is to be issued for the recovered stock. |
| Contact Information |
1300 309 994 - Aurora BioScience |