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.

FDA logo

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.


Share this Story

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.