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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 Medical Developments International Limited
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