Separation could result in required intervention to prevent permanent impairment/damage.
9/13/2017 6:00:00 PM
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
9/12/2017 4:00:00 AM
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
9/8/2017 6:00:00 PM
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
9/7/2017 4:00:00 AM
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
9/6/2017 5:00:00 PM
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
9/6/2017 1:00:00 PM
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
9/5/2017 7:00:00 PM
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
9/1/2017 4:00:00 AM
The use of these alcohol pads and antiseptic towelettes could cause infections.
9/1/2017 4:00:00 AM
Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
8/31/2017 3:00:00 PM
If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.
8/31/2017 12:00:00 PM
Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems.
8/30/2017 11:00:00 PM
There is a reasonable probability of the following side effects of topical steroids which include but are not limited to skin changes, adrenal suppression, glaucoma, and cataracts.
8/30/2017 10:00:00 PM
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
8/30/2017 3:00:00 PM
Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.
8/29/2017 5:00:00 PM
Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device.
8/28/2017 4:00:00 AM
Use of a product that may contain B. cepacia could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
8/23/2017 4:15:00 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
8/18/2017 7:30:00 PM
Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
8/16/2017 4:00:00 PM
Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.
8/16/2017 11:00:00 AM
Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.
8/10/2017 8:00:00 PM
Reports of B. cepacia infections in patients.
8/10/2017 7:45:00 PM
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
8/10/2017 3:00:00 PM
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
8/10/2017 3:00:00 PM
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
8/8/2017 4:00:00 AM