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Recent Posts in FDA Category

  • FDA Warns of Exploding Medical Carts

    The U.S. Food and Drug Administration (FDA) has issued a warning to hospitals and healthcare providers about dangerous medical carts that can catch on fire and explode. Nearly every hospital and medical facility uses battery-powered mobile medical carts which are used to dispense medication, ultrasound machines, and other medical equipment. If not properly maintained, the lithium or lead acid ...
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  • Endoscope Infections Widespread in Hospitals & Medical Centers

    Severe infections in hospital patients around the country have been attributed to unclean and unsterilized endoscopes used in surgeries and routine examinations. It is believed that more than 30 patients have died in the last three years as a direct result of endoscope infections. The Food and Drug Administration (FDA) is investigating the causes and consequences. Unclean Clinic Conditions & Bad ...
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  • The FDA Updates IVC Filter Health Risk Warning

    Inferior vena cava (IVC) filters have drawn heavy criticism and numerous lawsuits by patients who claim to have incurred injuries due device failure, manufacturer negligence, defective design, and misrepresentation. The U.S. Food and Drug Administration (FDA) has updated its communication warning of these potential health risks and has stated that IVC filters should generally not be kept in use ...
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  • Invokana and Invokamet Linked to Limb Amputations

    On May 18, 2016, the FDA issued a safety communication that warns of increased risk of leg and foot amputations with Invokana and Invokamet. These drugs are marketed by Janssen Pharmaceuticals (a division of Johnson & Johnson) and contain the SGLT2 inhibitor canagliflozin. SGLT2 inhibitors are used to treat Type 2 diabetes by causing the kidneys to remove excess glucose from the body through the ...
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  • What You Should Know About Laparoscopic Power Morcellators

    Laparoscopic power morcellators have garnered a negative reputation in recent years as being far more dangerous than they are useful. But why? What do morcellators do that has the Food and Drug Administration (FDA) worried and doctors across the country extremely hesitant to even get near one of the devices? To get to the bottom of the issue, there are a few frequently asked questions about power ...
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  • FDA ISSUES RECALL NOTICE ABOUT QUEST MEDICAL'S MPS DELIVERY SETS

    The FDA recently warned healthcare professionals of a recall of MPS Delivery Sets by Quest Medical, Inc. The Sets are used to deliver solutions to the heart during cardiopulmonary bypass surgeries. Quest Medical has recalled certain lots of these defective medical devices that were distributed between June 2015 and September 2015. The reason for the nationwide recall is a "seal failure along the ...
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  • FDA ISSUES RECALL NOTICE ABOUT SYNCARDIA'S FREEDOM DRIVER SYSTEM

    The FDA recently warned healthcare professionals of a recall of Freedom Driver System by SynCardia Systems. The Freedom Driver System operates and monitors SynCardia's Total Artificial Heart, which serves as a temporary "mechanical replacement for a patient's heart." SynCardia Systems has recalled certain lots of these defective medical devices that were distributed between November 2014 and July ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

    The FDA recently warned healthcare professionals of a recall of Hudson RCI Endobronchial Tube by Teleflex Medical. These tubes are inserted through the mouth into the bronchi of the lungs and are "used during a medical procedure that determines how well a lung is working." In the US alone, Teleflex Medical has recalled over 62,000 of these defective medical devices that were distributed between ...
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  • FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

    By Kaiser Gornick LLP posted in Defective Medical Devices on Monday, August 17, 2015 The FDA recently warned healthcare professionals of a recall of Beacon Tip Angiographic Catheters by Cook Medical. These angiographic catheters "are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions." In the US alone, Cook Medical has ...
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  • FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

    The FDA recently warned healthcare professionals of a recall of TigerPaw System II by Maquet Medical Systems. The TigerPaw System II "is a surgical staple used to close tissue in the left atrial appendage," a muscular ear-shaped pouch in the heart. Maquet Medical Systems has recalled all lots of these medical devices that were distributed between April 2013 and March 2015. The reason for the ...
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  • FDA ISSUES RECALL NOTICE ABOUT MYLAN INJECTABLE PRODUCTS

    The FDA recently warned healthcare professionals of a recall of various injectable medications by Mylan N.V. These pharmaceuticals include gemcitabine, carboplatin, methotrexate, and cytarabine, which are mostly used to treat various types of cancer. Mylan has recalled certain lots of these injectable products that were distributed in 2014. The reason for the nationwide recall is "the presence of ...
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  • FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

    The FDA recently warned healthcare professionals of a recall of Plum A+ and Plum A+3 Infusion Systems by Hospira. These devices are used to deliver fluids, including "critical intravenous medication... into a patient's body in controlled amounts." Hospira has recalled infusion pumps manufactures and distributed between July 2012 and May 2014. The reason for the recall is faulty alarms that may ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

    The FDA recently warned healthcare professionals of a recall of MAQUET Servo Humidifier 163 by Teleflex Medical. These devices are "placed over a surgically-created opening in the throat or a tube inserted into the trachea to warm and moisten gases breathed in by a patient." Teleflex Medical has recalled certain lots of the humidifiers distributed between June 2013 and November 2014. The reason ...
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  • FDA ISSUES SAFETY ALERT ABOUT INFECTION RISKS WITH DUODENOSCOPES

    The FDA recently issued a safety communication about potentially serious health risks associated with the use of ERCP endoscopes (also called duodenoscopes). These medical devices are "flexible, lighted tubes that are threaded through the mouth, throat, stomach, [in order to reach] the small intestine [or duodenum]." Their use "allows the injection of contrast dye [for imaging] or the insertion of ...
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  • FDA STRENGTHENS MARKETING REQUIREMENTS FOR DEFIBRILLATORS AFTER NUMEROUS DEVICE FAILURES

    The FDA recently issued a final order requiring "more rigorous review" of automated external defibrillators (AEDs) in order to improve the safety and reliability of such medical devices on the market. AEDs are portable devices used to "provid[e] a rapid response to victims of cardiac arrest" by "automatically analyz[ing] the heart rhythm... and deliver[ing] an electrical shock to the heart to ...
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  • FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

    The FDA recently warned healthcare professionals of a recall of Halyard Health's KimVent* Microcuff* Endotracheal Tubes. These devices are plastic tubes "inserted into the windpipe (trachea)... to open an airway for mechanical breathing [or]... to remove fluid that builds up in the windpipe during a procedure." Halyard Health has recalled endotracheal tubes distributed between December 2013 and ...
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  • ANTIPSYCHOTIC DRUG COULD CAUSE FATAL SKIN REACTIONS

    The FDA recently issued a safety warning about a serious condition associated with the use of the antipsychotic drug ziprasidone. Also marketed under the brand name Geodon, this drug is used to treat schizophrenia and bipolar disorder. The FDA warning cautions that taking ziprasidone could cause "a rare but serious skin reaction" known as DRESS. The condition could "start as a rash that can spread ...
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  • FDA ISSUES RECALL NOTICE ABOUT SIEMENS RAPID GRAM NEGATIVE COMBO PANELS

    The FDA recently warned healthcare professionals of a recall of Siemens Healthcare Rapid Gram Negative Combo Panels. These devices are used to measure how certain bacteria respond to various types of antibiotics. Siemens Healthcare has recalled combo panels distributed between December 2013 and September 2014. The reason for the recall is that using the devices may lead to incorrect test results ...
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  • FDA ISSUES RECALL NOTICE ABOUT GEMSTAR INFUSION PUMP POWER SUPPLY

    The FDA recently warned healthcare professionals of a recall of Hospira's Wall Mount and Desk Top GemStar Power Supplies. These accessories provide power to the GemStar Infusion Pump, which is "used to deliver controlled amounts of fluids including medicines, blood, [and] nutritional foods... into a patient's body..." Hospira has recalled power supplies distributed between November 2011 and April ...
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  • FDA ISSUES RECALL NOTICE ABOUT PEDIATRIC ANESTHESIA BREATHING DEVICE

    The FDA recently warned healthcare professionals of a recall of Teleflex Medical's Hudson RCI Pediatric Anesthesia Breathing Circuits. These medical devices are used to administer medical gases to pediatric patients during anesthesia. Teleflex Medical has recalled breathing circuits with certain lot numbers distributed between June 2013 and May 2014. The reason for the recall is a defect that ...
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  • FDA WARNS AGAINST THE USE OF BO YING COMPOUND DUE TO RISK OF LEAD POISONING

    The FDA recently warned healthcare professionals and parents not to use or purchase "Bo Ying compound." This powdered product is manufactured by Eu Yan Sang (Hong Kong) Ltd. and is marketed for treatment of various conditions in infants and children, such as influenza, fever, and nasal discharge. It is sold both in retail outlets and online. The FDA warning was issued after the New York City ...
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  • FDA ISSUES RECALL NOTICE ABOUT CARDIOVASCULAR SYSTEMS' DIAMONDBACK 360 BLOOD VESSEL TOOL

    The FDA recently warned healthcare professionals of a recall of Diamondback 360 Peripheral Orbital Atherectomy Systems. This medical device is inserted into patients' blood vessels and used "to reestablish blood flow in narrowed arteries." Cardiovascular Systems has recalled certain lot numbers of the device since "they may contain defective saline sheaths that could fracture during use." The ...
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  • FDA ISSUES RECALL NOTICE ABOUT CUBICIN

    The FDA recently warned healthcare professionals of a recall of Cubist Pharmaceuticals' Cubicin (daptomycin for injection). Cubicin is an intravenous antibiotic prescribed "for the treatment of skin infections and certain blood stream infections." Cubist Pharmaceuticals has recalled nine lots of Cubicin shipped between September 2013 and December 2013 due to the presence of foreign particulate ...
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  • FDA ISSUES RECALL NOTICE ABOUT GE'S E-MINIC CO2 DETECTORS

    The FDA recently warned healthcare professionals of a recall of GE Healthcare E-miniC Airway Modules and accessories. These medical devices are used in "health care facilities for monitoring CO2 [carbon dioxide] and respiration rates in patients weighing over 11 pounds." GE Healthcare has recalled modules with certain serial numbers because of a defect that could cause them to fail or provide ...
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  • MEDICAL DEVICES USED IN MINIMALLY INVASIVE SURGERIES COULD LEAD TO SPREADING OF CANCEROUS TISSUE

    The FDA recently issued a safety communication about the health risks associated with the use of laparoscopic uterine power morcellators. These medical devices are often used during various types of minimally invasive surgeries involving the uterus. Many women undergo such types of surgery due to "shorter post-operative recovery time and a reduced risk of infection", among other benefits. However, ...
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