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April 19, 2018 at 12:00 AM
Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
April 19, 2018 at 12:00 AM
NGB Corp. of West Jordan, Utah is voluntarily recalling NxtGen Botanicals Maeng Da Kratom labeled bottles of encapsulated product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can ressult in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
April 18, 2018 at 12:00 AM
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
April 18, 2018 at 12:00 AM
the recommended instructions and device design for the ERBEFLO port connector do not adequately mitigate the risks of cross-contamination for endoscopy patients. This is because the connector, tubing, and/or water bottle can become contaminated with blood, stool, or other fluids from previous patients that travel back through the endoscope channels into the connector and tubing. Endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing are known as 24-hour multi-patient use endoscope connectors. To date, the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their useTo mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.
April 18, 2018 at 12:00 AM
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
April 17, 2018 at 12:00 AM
If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. Posted 04/17/2018
April 13, 2018 at 9:00 AM
Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion.
April 13, 2018 at 12:00 AM
FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.
April 12, 2018 at 10:00 AM
Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection.
April 10, 2018 at 2:50 PM
System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope.
April 10, 2018 at 10:50 AM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
April 09, 2018 at 1:00 PM
Sales restricted to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.
April 03, 2018 at 2:00 PM
Salmonella bacteria can cause the foodborne illness salmonellosis. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection.
April 03, 2018 at 10:50 AM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
April 02, 2018 at 1:40 PM
Use of the contaminated product could result in an increased risk of infection.
March 26, 2018 at 10:30 AM
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
March 23, 2018 at 11:10 AM
Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
March 23, 2018 at 8:00 AM
UPDATED 03/23/2018. Recall expanded to include additional lots. Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
March 22, 2018 at 10:15 AM
Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
March 20, 2018 at 9:00 AM
UPDATED 03/20/2018. Recall expanded to include additional lots. Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
March 16, 2018 at 1:00 PM
Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
March 16, 2018 at 9:00 AM
UPDATED 03/16/2017. Glutamine in United Pharmacy’s compounded GAC 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
March 12, 2018 at 12:15 PM
Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
March 12, 2018 at 11:00 AM
Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
March 06, 2018 at 12:00 AM
An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018