MedWatch Safety Alerts

Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning

UPDATED 3/4/2015. The Safety Communication has been updated. Updated Information for Healthcare Providers Regarding Duodenoscopes is provided.

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Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke

FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.

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HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge

Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.

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Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance

Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.

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Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit

Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.

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MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures

Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.

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Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility

Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

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