| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00232-1 |
| Product Name/Description |
Halyard Closed Suction Kits with Flex Connector
Multiple Product Types
ARTG Number: 259994
(Halyard Australia - Catheter, suction, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Halyard Australia has been made aware of overseas reports indicating certain Flex Connectors supplied with 'Halyard Closed Suction with Flex Connector' devices may become loose or disconnect before use or during use. If disconnection occurs during use, it will result in an open respiratory circuit and interruption of patient ventilation.
To date, there have been no reports of permanent patient injury as a result of this issue. No reports of disconnect have been received from Australian facilities to date. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Halyard is advising:
- Before using the Flex Connector, evaluate its connection to the Swivel Connector of the Closed Suction adapter to ensure an adequate connection. Evaluation of the connection can be accomplished by pushing the Flex Connector onto the Swivel Connector. Users should refer to the images provided on the Customer Letter to establish whether an adequate connection has been obtained.
- If a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector and ensure adequate connection.
This action has been closed out on the 21/11/2018. |
| Contact Information |
1800 101 021 - Halyard Australia |