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Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port

The FDA is aware that Ambu Inc. is recalling the SPUR II resuscitator due to the manometer port being blocked, which renders the manometer non-functional. This defect can lead to an increased risk of harm caused by pressure changes (barotrauma) and delayed ventilation, since the ventilation pressure applied with Ambu SPUR II cannot be read on the manometer.

The use of affected product may cause serious adverse health consequences, including barotrauma, collapsed lung (pneumothorax), and death. 

There have been no reported injuries or deaths related to this issue.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact their local sales representative.