MedWatch Safety Alerts

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

UPDATED 02/23/2015. Patients may be exposed to serious infections.

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Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials

Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.

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