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.
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.
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.
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.
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.
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
UPDATED 02/23/2015. Patients may be exposed to serious infections.
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.