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serious health consequences 23 articles

Fifteen injuries linked to defective jaw implant; device has been recalled

Certain implants used in adults, children and infants to lengthen and stabilize the lower jawbone or side jaw to correct birth defects or post-traumatic defects are being recalled because the device may reverse direction. To date, this device defect has caused 15 injuries in patients. The recall involves the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). It is also referred to as an External Mandibular Fixator, External Mandibular Distractor and a Bone Plate. Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur, leading to ... Read More

Newborn head and body support products recalled due to presence of mold

Children’s Medical Ventures is recalling its Gel-E Donut and Squishon 2 products used in hospitals to support and cradle an infant’s head or body because of numerous complaints about visible mold on the outer surface of the products. The mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium can cause several different types of invasive infections including skin, eye, sinus and brain infections and those most vulnerable include newborns, critically ill patients, and patients with impaired or weakened immune systems. Both Cladosporium and Penicillium Fungi can cause difficulty breaking or allergic reaction. The recall is classified ... Read More

Medtronic recalls drainage and monitoring system due to potentially dangerous defect

Medtronic is recalling its Duet External Drainage and Monitoring System, a device that externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP), because the patient tubing line may separate from the patient line connectors. This is more likely to occur during frequent handling, such as when injections or sampling is needed. This defect could cause air in the skull, a condition known as pneumocephalus; infections such as meningitis, ventriculitis, or encephalitis; and over or under drainage of the cerebrospinal fluid that could lead to serious adverse health consequences, including death. To date, there have been no reports ... Read More

Diabetes test strips recalled due to labeling error

Diabetic Supply of Suncoast, Inc. has issued a recall of all BMB-BA006A Advocate Redi-Code+ test strips manufactured by BraodMaster Bio-Tech Corp due to a labeling error that could cause confusion about which meter models the test strips can work with. This is the third recall of diabetic test strips in the past year. In the affected Suncoast lots, the test strip model code (BMB-BA006A) was omitted. Suncoast issued the recall to avoid confusion and the possible misuse of the test strips with the wrong blood glucose meter. Using the test strips with the wrong meters can cause false readings. Falsely ... Read More

Baxter infusions pumps recalled after 3,500 incident reports

Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps after receiving 3,500 reports of system error incidents in which the device has malfunctioned resulting in nine adverse events. Infusion pumps are designed to deliver fluids such as nutrients or medication into a patients’ body in a controlled manner. A malfunction can result in a delay in therapy, which can lead to serious health consequences including death. The recall affects Baxter Healthcare’s Sigma Spectrum Infusion Pumps with Master Drug Library, models 35700BAX and 35700ABB. The incident reports involve a System Error 322 “Link Switch Error (low),” which occurs when the pump improperly ... Read More

Trilogy Ventilators recalled due to potentially dangerous defect

Approximately 600 Philips Respironics Trilogy Ventilators are being recalled because of a defective component on the power management board that could affect the function of the device. If not corrected, it is possible that the ventilator may fail to deliver mechanical breaths and that the ventilator failure alarm may not sound, which could lead to serious health consequences or death. Ventilators are machines designed to mechanically move breathable air into and out of the lungs, to provide the mechanism of breathing for a patient who is physically unable to breathe, or not breathing sufficiently enough. These devices are primarily used in ... Read More

Tandem Diabetes Care recalls t:slim Insulin Pump cartridges

Tandem Diabetes Care is recalling specific lots of insulin cartridges used with the its t:slim Insulin Pump because the cartridges may leak, resulting in the delivery of too much or too little insulin. If this occurs, it could have serious health consequences for patients using the device. Affected lots of the insulin cartridges were shipped on or after December 17, 2013. Approximately 4,746 boxes, containing 10 cartridges each, are affected by the recall. Doctors, pharmacists and consumers who have the affected lots are asked to discontinue using using the cartridges immediately. Affected Lot Numbers include the following: M001963, M001980, M002027, ... Read More

Nitroglycerin infusion recalled due to possible contamination

One lot of nitrogylcerin infusions used to treat heart patients is being recalled by the manufacturer because of possible contamination that could cause a blockage of blood vessels and other potentially serious health consequences. The recall involves nitroglycerin in 5% dextrose injection made by Baxter. The affected lot may contain particulate matter that if injected has the potential to cause venous and/or arterial thromboembolism, or a blockage of blood vessels. Other potential adverse events that can arise from the contaminated vials include inflammation, particularly in the lungs, and local irritation of blood vessels. Nitroglycerin in 5% dextrose injection is an ... Read More

Fresenius asks Missouri officials to send back drug it intended to use for executions

Fresenius Kabi, one of four business segments of the worldwide dialysis giant Fresenius Medical Care, is playing hardball with one of its U.S. wholesalers for mistakenly selling its anesthetic propofol to the state of Missouri, which purchased it for use in executions. German drug maker Fresenius made its wholesalers sign contracts agreeing they wouldn’t sell the drug to states for use in executions. The death penalty is not practiced in Europe, and Germany has a law that does not allow the export of medications for such uses. Fresenius was being pressured not to sell propofal in the United States because of the ... Read More

Stryker warns of defect with implantable plate used to stabilize spine, issues urgent recall

Stryker Spine is warning doctors and patients of a defect with the OASYS Midline Occiput Plate, which is used in spinal surgery to stabilize the skull and spine at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine. It has been identified that, after surgery, the pin that connects the tulip head to the plate can break, which can lead to destabilization of the plate. This could cause serious health consequences including blood loss, nerve injury and revision surgery to repair the problem. Stryker has sent an Urgent Medical Device Recall notice to medical facilities ... Read More