| TGA Action ID |
RC-2025-RN-00814-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Salem Sump
Multiple product descriptions and product codes |
| ARTG Number |
319261 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Cardinal Health received complaints regarding the Anti-Reflux Valve (ARV) breaking due to user error. The ARV failures are attributed to excessive force during use. Based on this, Cardinal Health is providing additional guidance when using these products in the Instructions for Use (IFU).
125 complaints have been reported globally with zero confirmed incidents reported in Australia. |
| Instructions for Customers/Users |
The electronic Instructions for Use (IFU) are in the process of being updated with the additional guidance and will be posted on the sponsors website in the coming weeks https://www.mycardinalmsds.com.
In the interim customers are to follow the additional guidance in the customer letter:
After placement of the Salem Sump tube, always inject 10ml-20ml of air before seating the Anti Reflux Valve (ARV) into the blue sump vent lumen.
Instructions:
1. Seat the BLUE END of the ARV into the blue sump vent lumen of the Salem Sump tube. Insert the ARV gently into the Salem Sump tube to avoid difficult removal.
2. To cap tube, seat the WHITE END of the ARV into the suction lumen. Insert the ARV gently into the Salem Sump tube to avoid difficult removal.
3. To remove, pull valve in the same direction of assembly. Do not pull at an angle to avoid breaking the valve.
This action has been closed out on 14/05/2026 |
| Action Commencement Date |
1/10/2025 |
| Responsible Entity |
|
| Contact Information |
ANZ.Recall@cardinalhealth.com - Cardinal Health Australia |