| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00058-1 |
| Product Name/Description |
BVM (Bag-Valve-Mask) Manual Resuscitation Systems
Reference Number: 7150000, 7151000, 7152000, 7153000, 715400
Lot Numbers: 7150000 – 372894, 7151000 – 372886, 7152000 – 372893, 7153000 – 372892, 7154000 – 370753
ARTG Number: 225855
(Intersurgical Australia Pty Ltd - Resuscitator, pulmonary, manual, single use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
A manufacturing fault has been identified with the Intersurgical BVM Manual Resuscitation System, which could result in the directional valves positioned on the back plate of the self inflating bag being orientated incorrectly. The incorrect orientation of the directional valves could result in the BVM Manual System becoming over pressurised, which could result in patient barotrauma. |
| Recall Action |
Recall |
| Recall Action Instructions |
Intersurgical is advising users to inspect stock and quarantine affected units for return.
In instances where an alternative product is not available, Intersurgical is advising users to inspect each device before use to determine if it is affected by the issue. If the device is not affected, it can be safely used.
This action has been closed out on the 16/11/2018. |
| Contact Information |
02 8048 3300 - Intersurgical Representative |