| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00736-1 |
| Product Name/Description |
BVM (Bag-Valve-Mask) Manual Resuscitation Systems
Multiple Reference and Lot Numbers
ARTG Number: 225855 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Intersurgical has identified the possibility that the valve of the BVM Manual Resuscitation System may become stuck during storage. This could result in the
intended tidal volume not being delivered through the valve, which may cause a delay in treatment.
The Instructions For Use (IFU) provided with these products includes the requirement to ensure that the bag, valve and oxygen delivery are functioning correctly prior to use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are asked to inspect their stocks and quarantine all units from the above lot numbers, then complete the attached Reply Form and email or fax it to us so that we may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile this process.
This action has been closed out on 31/10/2018 |
| Contact Information |
02 8048 3300 - Intersurgical Australia |