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adverse health consequences 4 articles

Hospital CO2 detector accessories recalled due to life threatening defect

GE Healthcare is recalling accessories for its CO2 detectors because they may cause the device to fail or to provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians rely on these devices to make decisions, and if those decisions are based on incorrect readings from these machines, permanent, irreversible impairment or life threatening changes could occur in patients, such as inadequate exchange of gasses (hypoventilation), causing an increased concentration of CO2 (hypercapnia), which can be deadly. The recall involves GE Healthcare single-width airway modules (E-MiniC) and accessories and Extension Modules (N-FC, N-FCREC). It is classified as a Class ... Read More

Testing shows calcium injections were contaminated with dangerous bacteria

The Food and Drug Administration (FDA) is urging health care professionals to follow up with patients treated with injections of calcium gluconate 10% made by Rx Formulations between Nov. 7 and Dec. 11, 2013. Testing on the product has confirmed the presence of microbial contamination, specifically gram-positive rod bacteria, which could cause adverse health consequences and possibly serious infection. Calcium gluconate is used to treat calcium deficiency and postmenopausal osteoporosis. It also treats black widow spider bites, lead colic, overdose of magnesium or certain heart medicines, and a condition called rickets. It is also used in life support and life-threatening ... Read More

Reports of death, infection prompt recall of SafeSpout, SafeShower water filtration systems

The Food and Drug Administration (FDA) has ordered a Class 1 recall following a death and an infection linked to Nephros-brand non-medical water filtration systems. SafeSpout and SafeShower products can expose users to harmful bacteria or viruses when the fiber filter or the sealing compound holding the filter in place breaks apart. This can cause serious infections and death. A Class 1 recall is the most serious recall and involves situations in which there is a reasonable probability that use or exposure to the product will cause serious adverse health consequences or death. SafeSpout and SafeShower products are designed to filter ... Read More

FDA proposes new rules for food, drug, device recalls

Recalls of food, drugs and medical devices continue to make headlines as the Food and Drug Administration (FDA) works to implement the Food Safety Modernization Act (FSMA) and focus on compliance with current good manufacturing process (CGMP) requirements with all FDA-regulated products. As part of this effort, in January 2013 the FDA proposed a rule that would require manufacturers of food to maintain a recall plan that would evaluate the severity and scope of the recall; notify the FDA, consumers and the public; and secure insurance coverage for potential losses and liabilities. Manufacturers with no experience writing recall plans or ... Read More