From the category archives:

MedWatch

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

February 27, 2015

Electrostatic discharge event could result in a pump stop, which could cause serious injury or death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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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

February 25, 2015

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. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full [...]

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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

February 25, 2015

Risk of life-threatening injuries or death if a metal object is brought into the magnetic field. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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

February 24, 2015

Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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

February 19, 2015

Patients may be exposed to serious infections. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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

February 11, 2015

Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch [...]

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Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall – Balloon Inflation Ports Mislabeled

February 11, 2015

The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you [...]

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0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall – Particulate Matter

January 23, 2015

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication – Reports of Serious Injuries

January 21, 2015

Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Simulated IV Solutions from Wallcur: CDER Statement- FDA’s Investigation into Patients being Injected

January 14, 2015

Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch [...]

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