| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00147-1 |
| Product Name/Description |
Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders
Figulla Flex II ASD
Product Code: 29ASDxx
Figulla Flex II PFO
Product Code: 19PFOxxD
Occlutech PDA Occluder
Product Codes: 42PDAxx, 42PDAxxL, 43PDAxxL
Multiple Lot Numbers
ARTG Numbers: 201602, 201603, 219523 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Occlutech has received a report whereby a customer inadvertently used an expired Occlutech Flex II Pusher cable and noticed doing so shortly after the implantation procedure. There was no impact on the patient, the procedure or the product performance. Occlutech Occluders and compatible pusher cables are packaged together into an Occlutech product set which also contains the Instructions for Use and the Patient Information card. The outer label on the Occlutech product set clearly shows the expiration dates of both the Occluder and the Pusher cable. As these dates can differ from each other, it is important to check both dates to not miss the shortest expiration date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Occlutech will in future be implementing a revised Occlutech product set label showing only the shortest expiry date. For current inventory, Getz Healthcare is advising customers to immediately check the expiration dates of the Occlutech Occluder and of the pusher cable as printed on the outer box-label of all products in their current inventory. If one of the expiration dates is exceeded, customers are to block and remove the Occlutech Occluder set containing the expired product from their inventory. Getz will replace all expired stock. End-users are also advised to carefully routinely review the Occutech Occluder set labels prior to use, in accordance the Instructions for Use.
This action has been closed-out on 01/03/2018. |
| Contact Information |
02 9413 6212 - Getz Healthcare |