| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01505-1 |
| Product Name/Description |
Vacuette Minicollect Complete 1mL Sodium Citrate 3.2%.
An in vitro medical device.
Item Number: 450556
Batch Number: A17083KP
ARTG: 256074 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Interpath have become aware of an issue regarding inconsistent volumes of citrate present in a certain batch of the Vacuette Minicollect Complete 1mL Sodium Citrate 3.2% tubes which may affect patient results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Interpath is advising customers to inspect stock and quarantine all tubes of batch A17083KP. Customers should then complete the reply form provided with the Customer Letter so Interpath may arrange for stock to be recovered and replacement stock issued.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
(03) 9457 6277 - Interpath Services |