If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
FDA will update recall with new information as it becomes available.
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.