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Safety notice and recall of resuscitation bag valve mask

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent field safety notice in relation to the bag valve mask (BVM) manual resuscitation system manufactured by Intersurgical. More than 45 lots are potentially affected by the defect.

A manufacturing fault has been identified with system which could result in the directional valves positioned on the ‘back plate’ of the self-inflating bag to be orientated incorrectly. The incorrect orientation of the directional valves could result in the BVM Manual System becoming over pressurised, which could result in lung damage due to delivery of excessive pressure.

The MHRA is advising that affected devices should be immediately identified and quarantined. Alternative devices should be used where available. If no alternative is available, the advice from the MHRA is to check all valves on the BVM before releasing the product from quarantine. This can be done without opening the packaging. If the orientation of the valves is incorrect, the device should not be used.

Affected devices should be returned to the manufacturer along with a response form, and any adverse events involving these products should be reported to Intersurgical.

BVM Manual Resuscitation Systems with separate directional valve housing are not affected by this field safety notice and are safe to use.


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