| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00228-1 |
| Product Name/Description |
Surgical procedure kit, cardiothoracic, non-medicated, single-use: Custom Tubing Pack
Multiple products and catalogue numbers
ARTG 161865
(LivaNova Australia Pty Ltd - Surgical procedure kit, cardiothoracic, non-medicated, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
LivaNova Australia has detected some defects in the plastic header bags used as the outer packaging of the attached list (attachment 2) of Custom Tubing Packs. The defects are minor and sporadic scratches on the header bag.
LivaNova is concerned that some of the defects may jeopardise the sterility of the Custom Tubing Packs. List of potential affected catalog numbers is provided below.
This recall does not affect any other Custom Tubing Packs that is not listed in the attachment 2.
To date, there have been no reports of adverse events related to this problem. Only one complaint of damaged header bag was received, and the defect was identified at setup prior to use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1. With the help of table 1 in attachment 2, identify and quarantine the potentially affected Custom Perfusion Tubing Packs.
2. If use of the packs is needed, inspect them carefully before use as indicated in the product IFU in section “CAUTIONS AND WARNING” point 9. “Do not use this set if the packaging is pierced or torn. Sterility is guaranteed only if the sterile packaging is not wet, opened, damaged or broken. Do not use if sterility cannot be guaranteed.”
3. Fill in and sign the Customer Response Form (Attachment 1) and return it by email to LivaNova.FSCA@livanova.com or by hand to your LivaNova contact person, to confirm that you have received this letter, you have read and understood its content.
4. Upon return of Attachment 1 to LivaNova Australia, a LivaNova Representative will be in contact to organise and perform a 100% inspection at your facility to remove any possible defective Custom Perfusion Tubing Packs. |
| Contact Information |
LivaNova.FSCA@livanova.com - LivaNova Quality Assurance Team |