| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00619-1 |
| Product Name/Description |
AbbVie Percutaneous Endoscopic Gastronomy and Jejunal tubing kits (AbbVie PEG and AbbVie J)
(used for administration of medication Duodopa (Levodopa Carbidopa) Intestinal Gel)
AbbVie PEG 15 R
Product Code: 62941-001
AbbVie J Intestinal Tube 9 FR for PEG 15 FR
Product Code: 62943-001
All lots may be affected.
ARTG Numbers: 223443 and 223444 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
AbbVie has identified the potential for missing components and / or duplicate components in the AbbVie PEG 15 R and AbbVie J Intestinal Tube 9 FR for PEG 15 FR kits. The reported events of missing components have not been associated with any reports to AbbVie of related serious injury and it is unlikely for the missing components to pose any significant safety risk. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AbbVie is advising users to inspect the kits using the product’s Instructions for Use, product description section to ensure all components are present before proceeding with implantation. Any missing components are to be reported to AbbVie, including details of the device lot number, and the kit returned to AbbVie. AbbVie will provide replacement kits if there are missing components.
This action has been closed out on 18/09/2018 |
| Contact Information |
1800 043 460 - AbbVie |