| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01150-1 |
| Product Name/Description |
Regulator Click Style Medical Oxygen 25 L/min 2 Self Seal SIS, 1 Hose Barb
Product code: 286MB-25LY2A
ARTG 176047
(Tesuco Pty Ltd - Regulator, gas, high-pressure) |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/08/2022 |
| Responsible Entity |
|
| Reason/Issue |
Tesuco advise that in some instances, the gas specific sleeve index collar for the GENTEC 286MB 25LY2A Oxygen Regulators may be easily unscrewed by hand.
If the SIS collar is removed, the gas specific nature of the outlet fitting is lost and any gas type equipment may be connected to the device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Tesuco ask customers to:
1. Identify loose collars and note that they can be secured with the use of high strength thread lock adhesive as outlined in the instructions provided with the Customer Letter.
2. Alternatively devices may also be returned to Tesuco for corrective action.
Tesuco advises that the manufacturing procedure has been amended to include the application of high strength thread lock adhesive in the assembly stage to secure the collar and eliminate removal by hand.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
(02) 9737 9937 - Technical Sales Manager |