Device failure could lead to embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment.
The affected lots may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with
the affected baclofen, especially when administered directly into the spinal column.
Use of product may increase the risk of fatal heart attack or stroke, especially if used long term or taken in high doses, or if there is a history of heart disease.
If ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Labeling changes describe risks of ketoacidosis, urosepsis and pyelonephritis.
Use of product may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis.
Manufacturing problem causes the affected thermometers to display temperatures that are lower than actual body temperatures, which may cause the user or caregiver of the user to delay or forego seeking appropriate care.
The use of affected product may cause serious adverse health consequences, including death.
Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated.
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