St ӧ ckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
St ӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - June 1, 2016 Category: American Health Source Type: alerts
Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
Manufacturing defect causes an increase in temperature within battery that may cause a fire. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 27, 2016 Category: American Health Source Type: alerts
Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect
Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage, which may result in serious adverse health consequences, including death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 26, 2016 Category: American Health Source Type: alerts
Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Posted 05/19/2016 (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 19, 2016 Category: American Health Source Type: alerts
Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 18, 2016 Category: American Health Source Type: alerts
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 18, 2016 Category: American Health Source Type: alerts
SOS Telecom Products: Recall - Undeclared Drug Ingredient
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 13, 2016 Category: American Health Source Type: alerts
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
FDA urges health care professionals to purchase drug products only from legitimate suppliers. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 13, 2016 Category: American Health Source Type: alerts
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
Serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 12, 2016 Category: American Health Source Type: alerts
Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 10, 2016 Category: American Health Source Type: alerts
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter
The presence of glass particulate matter could block drug administration, delaying therapy, and may also result in local inflammation, mechanical disruption of tissue, or cause an immune response. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 9, 2016 Category: American Health Source Type: alerts
Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 4, 2016 Category: American Health Source Type: alerts
Beacon Tip Technology Catheters by Cook Medical: Recall - Polymer Degradation of the Catheter Tip
Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 4, 2016 Category: American Health Source Type: alerts
