Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
8/22/2016 3:45:00 PM
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
8/19/2016 5:00:00 PM
Risk of sub-therapeutic dose as well as potential microbial contamination.
8/18/2016 6:20:00 PM
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
8/17/2016 1:30:00 PM
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.
8/15/2016 9:00:00 PM
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
8/12/2016 11:20:00 PM
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
8/12/2016 6:00:00 PM
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
8/9/2016 12:00:00 PM
Administration to a patient may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
8/5/2016 5:20:00 PM
Risk of serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
8/5/2016 1:00:00 PM
Administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
8/3/2016 12:30:00 PM
Topical administration of a product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
8/1/2016 7:30:00 PM
Ventilator shutdown may cause serious adverse health consequences, including death.
7/28/2016 6:20:00 PM
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
7/26/2016 4:01:00 PM
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
7/22/2016 6:15:00 PM
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
7/22/2016 2:00:00 PM
Reports of hair loss, hair breakage, balding, itching, and rash.
7/19/2016 5:00:00 PM
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
7/16/2016 4:00:00 AM
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
7/12/2016 7:30:00 PM
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
7/5/2016 4:30:00 PM
Batteries may lose power prematurely due to faulty cells.
6/29/2016 4:20:00 PM
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
6/14/2016 2:00:00 PM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
6/8/2016 6:20:00 PM
Sibutramine is known to substantially 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.
6/7/2016 6:55:00 PM
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
6/7/2016 1:00:00 PM