| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00994-1 |
| Product Name/Description |
Macopharma blood bags
Product Code: LQT6283LB
Multiple batches affected
ARTG Number: 142856
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2016 |
| Responsible Entity |
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| Reason/Issue |
Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (BAT) systems.The slits cut into the CV1014 pack are used to store the crossmatch line ‘pig-tails’. The hanging loop is used during the inversion of the pack to run additive into the concentrate red cells.
This recall action was undertaken prior to consultation with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016. |
| Contact Information |
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