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FDA MedWatch Safety Alerts
Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation
Risk of stroke, kidney injury, or damage to the intestines or limbs.
Posted: February 11, 2016, 12:45 pm
Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast
If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.
Posted: February 11, 2016, 12:30 am
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy
If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Posted: February 10, 2016, 6:00 pm
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient
May contain sibutramine, phenolphthalein, and/or diclofenac.
Posted: January 29, 2016, 5:00 am
Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.
Posted: January 28, 2016, 11:50 pm
Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels.
Posted: January 28, 2016, 7:50 pm
Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.
Posted: January 28, 2016, 5:00 am
The issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death.
Posted: January 27, 2016, 9:30 pm
Solution contamination could lead to a worsened patient condition or death.
Posted: January 27, 2016, 12:30 pm
Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall - Damage May Prevent Patient Therapy
Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient.
Posted: January 26, 2016, 7:50 pm
Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine
Effects of morphine can include, but are not limited to, severe allergic reactions, respiratory depression, and death.
Posted: January 16, 2016, 5:00 am
Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance
Products include injectable medications, sterile solutions, eye drops, and eye ointments.
Posted: January 16, 2016, 5:00 am
Potential inaccuracies in the display by the navigation system could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.
Posted: January 15, 2016, 6:20 pm
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
UPDATED 01/15/2016. FDA cleared the Olympus duodenoscope with modifications to device design & labeling intended to reduce the risk of bacterial infections.
Posted: January 15, 2016, 3:30 pm
Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup
An overdose of Guaifenesin DM may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor, and coma.
Posted: January 13, 2016, 2:00 pm
Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall - Catheter May Break During Insertion
May cause serious patient injury or death.
Posted: January 11, 2016, 5:00 am
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: January 9, 2016, 7:45 pm
Salmonella can cause fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Posted: January 8, 2016, 7:40 pm
Evita V500 and Babylog VN500 Ventilators by Dräger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly
If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause patient injury or death.
Posted: January 6, 2016, 2:15 pm
Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container
Potential for delay in treatment that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.
Posted: January 6, 2016, 2:00 pm