| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00105-1 |
| Product Name/Description |
Clements Suction Regulators
Models:
SUC89140 – High Vacuum High Flow Regulator
SUC89150 – Low Vacuum Low Flow Regulator
SUC89160 – Medium Vacuum Low Flow Baby Mucus Regulator
SUC89170 – Medium Vacuum High Flow Infant Regulator
SUC89180 – Low Vacuum Thoracic Regulator
ARTG Number: 239973 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Recent customer feedback has alerted BMDi TUTA Healthcare to an issue with the Sleeve Index System (SIS) on the handwheel coupling. This component is the interface between the regulator and the wall fitting. The groove in the handwheel has been manufactured with an incorrect dimension. Due to this incorrect dimension it is possible to incorrectly connect the suction regulator to the air outlet for surgical tools. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to examine all affected suction regulators installed in their facility and ensure that they are connected to the correct source. This can be identified by the yellow suction label on both the regulator and the wall outlet. BMDi TUTA will arrange for the sleeves to be shipped to affected facilities for rework. Rework the handwheel component in accordance with the rework instructions provided in the customer letter.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9466 5300 - BMDi TUTA Healthcare |