| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00086-2 |
| Product Name/Description |
Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)
BL200 BD Pre Post;
Product Code 114635,
Batch Numbers from 1240 to 1303
BL208BD;
Product Code:114557
Batch numbers from 1242 to 1304
BL223 PB;
Product Code: 114636
Batch Numbers from 1252
ARTG Number: 141589 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Gambro has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the Integra and AK machines. The new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Gambro is providing additional instructions for use for the correct blood level setting in the venous chamber. In addition, Gambro will discontinue the new design and re-introduce the original design. |
| Contact Information |
02 8852 3700 - Gambro |