| TGA Action ID |
RC-2026-RN-00526-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VariVac Wound Drainage Kit
Product Code: VC500-02
All batches numbers |
| ARTG Number |
391602 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Instructions for Use (rev. 9) supplied with VariVac Wound Drainage Kit:
(1) do not state the intended purpose of the device;
(2) do not specify the expected negative pressure, variability range at each regulator/dial setting, or the maximum achievable vacuum; and
(3) do not include warnings against use in near delicate and sensitive tissues e.g. brain.
As a result, users may apply suction pressure materially different from that intended, potentially causing tissue trauma from excessive suction or inadequate drainage. |
| Instructions for Customers/Users |
Customers are to:
- Immediately distribute the revised IFU (rev. 11) to all clinical areas holding or using the device
- Replace/insert the revised IFU with remaining stock and discard the superseded IFU (rev. 9)
- Confirm completion via the Customer Response Form
This action has been finalised on 23/10/2026. |
| Action Commencement Date |
24/07/2026 |
| Responsible Entity |
|
| Contact Information |
(08) 9240 8291 - Sponsor Customer Service |