Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene UPDATED 09/04/2015. FDA is providing information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection. Originally posted 03/10/2015 Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed A patient not receiving enough oxygen can result in possible injury or death. Posted 09/02/2015 Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. Posted 09/02/2015 DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling. Posted 08/28/2015 OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. Posted 08/28/2015 Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. Posted 08/27/2015 Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump Over or under infusion of fluids to the patient has the potential to cause patient injury or death. Posted 08/27/2015 Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. Posted 08/26/2015
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