FDA Alerts & Warnings

Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

23. December 2011

Posted in: FDA Alerts and Warnings

CareFusion AVEA Ventilator: Recall – Failure May Lead to Lack of Ventilation

Ventilator may stop ventilating and result in life-threatening injury or death.

22. December 2011

Posted in: FDA Alerts and Warnings

Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.

22. December 2011

Posted in: FDA Alerts and Warnings

Eclectic Institute Dietary Supplements: Recall – Possible Salmonella Contamination

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

21. December 2011

Posted in: FDA Alerts and Warnings

ShoulderFlex Massager: Warning – Risk of Strangulation

Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.

21. December 2011

Posted in: FDA Alerts and Warnings

St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall – Failures with Lead Insulation

Premature insulation abrasion may cause the conductors to become externalized, which can cause serious adverse health consequences, including death.

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Respironics, Inc. Trilogy 100 Ventilators: Class I Recall – Device May Stop Delivering Therapy to Patient

Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall – Glass Particles

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory – Potential Safety Risk

Novartis Consumer Health Over-The-Counter Products: Recall – Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps

Ikaria INOmax DS Drug Delivery System: Class I Recall – Erratic Nitric Oxide (NO) Readings

CareFusion AVEA Ventilator: Recall – Failure May Lead to Lack of Ventilation

Liquid Acetaminophen marketed for infants: Drug Safety Communication – Potential for Dosing Errors

Eclectic Institute Dietary Supplements: Recall – Possible Salmonella Contamination

ShoulderFlex Massager: Warning – Risk of Strangulation

St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall – Failures with Lead Insulation

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