| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00838-1 |
| Product Name/Description |
BVM (Bag-Valve-Mask) Manual Resuscitation Systems
Catalogue Number: RS-7595-BVMDAW
Batch Numbers: up to 1170328006
Catalogue Number: RS-7595-BVMDA
Batch Numbers: up to 1160629050
Catalogue Numbers: RS-7595-BVMDC, RS-7595-BVMDC3
Batch Numbers: up to 1160728029
Catalogue Number: RS-7595-BVMDC3
Batch Numbers: up to 11600922002
ARTG Number: 147543 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medical Developments International 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 include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medical Developments International is requesting users inspect their stocks and quarantine all units from the affected batch numbers, then complete the supplied Reply Form and email or fax it back so that they may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, Medical Developments require this information to reconcile the process.
Action closed out on 22/08/2018 |
| Contact Information |
03 9547 1888 - Medical Developments International |