| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01151-1 |
| Product Name/Description |
Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity)
Product Codes: R54400, R54400-00-PP, R54410, R51400, R51400-00-PP, R51410
ARTG Number: 145658 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Rocket Medical is notifying customers the blue connector tube may not open once the white clip is removed due to a manufacturing irregularity. If this occurs the vacuum contained in the bottle will not be applied to the patient, therefore no fluid can be drained. If left, the connector tube will still open with a delay of up to 5-6 minutes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Rocket Medical is advising customers to open the tube by gently manipulating the tube forwards and backwards when the white clip has been opened. This action has been closed-out on 01/03/2016. |
| Contact Information |
02 9973 4349 - Rocket Medical |