8 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are eight reported to the FDA since February:

  1. Combat Medical Systems recalls convenience kits, cites possible needle damage
    Combat Medical Systems has recalled its convenience kits, which are used by military medical personnel to transfuse donor blood to patients on the battlefield, after discovering the needle in the blood pack may bend or disconnect from the blood bag.

  2. ACIST Medical Systems recalls ultrasound catheter
    ACIST Medical Systems has recalled its Kodama intravascular ultrasound catheter after finding the O-ring housing tubing may squeeze and damage the O-ring, which could cause the O-ring to break free and enter the patient's artery during use, which could cause a heart attack or stroke.
  1. Sagent Pharmaceuticals recalls blood pressure drug, cites lack of sterility assurance
    Sagent Pharmaceuticals has recalled three lots of phenylephrine hydrochloride injection, which is used to treat low blood pressure during surgery, because of  a lack of sterility assurance.

  2. Bryant Ranch Prepack recalls spironolactone, cites mislabeling
    Bryant Ranch Prepack has recalled 47 bottles of spironolactone, a blood pressure drug, after finding the bottles were mislabeled, displaying the incorrect strength.

  3. Medtronic recalls heart pump device after 2 patient deaths
    Medtronic has recalled a heart pump device after discovering it sometimes failed to start or restart, an issue that led to two patient deaths.

  4. Medical devicemaker recalls patient lift after 2 deaths reported
    Hillrom, a medical devicemaker based in Chicago, has recalled its patient overhead lift device after multiple reports of serious injuries and two patient deaths.

  5. Boston Scientific recalls defibrillator
    Boston Scientific has recalled its EMBLEM S-ICD defibrillator after identifying that a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high-voltage shocks.

  6. Medtronic recalls thoracic stent graft after patient's death
    Medtronic is recalling its Valiant Navion thoracic stent graft system after discovering three patients in a clinical trial had stent fractures and a report of one patient death.

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