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Medical device recalls for November 2012

Mon, 12/03/2012 - 4:01pm
Mass Device

Class I and class II recalls issued by the Center for Devices & Radiological Health in November 2012.

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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.

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