Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Pregnant women urged to discuss all medicines with their health care professionals before using them.
Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.
An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.
There have been reports of serious adverse events associated with the use of certain of these products.
Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer).
Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.
Serious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if taken with other medications that work similarly.
Can increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use.
Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.
Symptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.
FDA advises practitioners to approach the application of these interventions with caution.
UPDATED 12/09/2014. Expansion of Class I Recall. Significant discrepancy in INR results may lead to a delay in an urgent medical decision