| TGA Action ID |
RC-2025-RN-00356-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CompoStop Platelet Storage Systems
Article Code: FD51600
Multiple Batch Numbers |
| ARTG Number |
149449 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Fresenius Kabi has received 26 complaints with 43 confirmed defective units about leakages at the tube port. A leak in the sample bag could potentially lead to a microbial contamination in the product storage bag if undetected.
Investigation found this type of defect to be recognisable by the user under routine handling conditions, and that the likelihood a leakage leading to microbial contamination is improbable. |
| Instructions for Customers/Users |
Customers are to follow the IFU:
- When working with the CompoStop products
- In case of visible damage do not use the product
- Use a sample kit (P4206 - CompoFlex 1F 100ml sample system) to collect a new sample in case of a leak of the sample bag
No alternative stock is available currently. Fresenius will provide additional advice when alternative stock is expected to be available. |
| Action Commencement Date |
1/04/2025 |
| Responsible Entity |
|
| Contact Information |
1300 732 001 - Customer Service |