| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00065-1 |
| Product Name/Description |
EQUASHIELD® Closed System Transfer Device, Spike Tubing
Item code: SA-1E
Lot numbers: 216758A, 218796A, 2214644A, 2214936A, 2215238A, 2215434A, 2315884A, 2317211V, 2317767A
ARTG 228376
(REM Systems Pty Ltd - Compounding transfer set) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
A small number of SA-1E Spike Tubing from specific lot numbers, may be affected by a packaging defect where the packing heat seal has cut the tubing of the device.
Where this defect occurs, the line may be cut and spillage may occur during use.
If the Spike Tubing Set is to be used with hazardous drugs, the user and/or patient may be exposed to those hazardous drugs.
The affected lots have been distributed to hospitals and hospital pharmacies since March 2021. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Customers must:
-Visually inspect the tube for any cuts. This important step will identify any defect prior to use with hazardous drugs.
- If affected stock is identified on visual inspection or during the priming step, the product should not be used and quarantined, as well as REM SYSTEMS notified to arrange for the return and credit of any affected stock. |
| Contact Information |
1800 737 222.- REM Systems Pty Ltd |