Medical device recalls for November 2012
Class I and class II recalls issued by the Center for Devices & Radiological Health in November 2012.
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Ventlab Corporation Nov-01-2012 Breath Tech; Safe Spot Infant Resuscitator - Breath Tech; Safe Spot Infant Resuscitator; BT2000 Series; Single use; Manufactured by: Ventlab Corporation; 155 Boyce Drive; Mockville; NC 27028.The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea; commonly associated with cardiopulmonary arrest. Possible volume leakage through the inlet valve during compressions of the resuscitator bag.