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News Archives

December 9, 2016: Centurion Catheters Recall Due to Possible Excess Material in the Bloodstream

Centurion Convenience Kits containing Multi-Med Single Lumen Catheters are subject to a recall due to Excess Material that May Split or Separate. This device is used to sample blood, and administer drugs or fluids. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. However, when this dangerous situation occurs, excess material may remain at the tip of the catheter from the manufacturing process. The excess material may separate from the catheter during use and enter the patient’s bloodstream. Adverse Effects According to the FDA Press Release, the FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Excess material entering the bloodstream may result in serious adverse health consequences such as the development of Read More

October 4, 2016: Flush Syringes Burkholderia Infection Link – Nurse Assist, Inc. Announces Recall

Flush Syringes Burkholderia Infection Link Prompts Recall – Nurse Assist, Inc. announced on October 4, 2016, that the company is recalling all unexpired lots of I.V. Flush Syringes because the products may be linked to Burkholderia cepacia systemic infections. According to CDC, B. cepacia poses little medical risk to healthy people; however, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to B. cepacia infection. B cepacia is a known cause of infections in hospitalized patients. Flush Syringes Burkholderia Infection Link – Product Recall Information According to a company press release, the Nurse Assist Flush Syringe recall affects the following lots and part numbers: “ Product Code: 1203; Product Description: IV Flush Syringe, 3ml fill; Lot Number: All unexpired lots Product Code: 1205; Product Description: IV Flush Syringe, Read More

August 19, 2016: Honeywell Issues Eyewash Recall Due To Potential Contamination

Eyewash Recall News – Honeywell has issued a recall for one production lot of 32-ounce bottles of Eyesaline Eyewash solution because the product has the potential to be contaminated with Klebsiella pneumonia. The recalled eyewash is used for emergency eye rinsing after an injury. About Klebsiella According to the U.S. Centers for Disease Control and Prevention (CDC) Klebsiella is a type of “bacteria that can cause different types of healthcare-associated infections, including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis.” Although Klebsiella can be found in the intestines of healthy individuals, it can cause infections in the frail or in individuals who are exposed to the bacteria as the the result of certain medical procedures or products. For example, a patient can be exposed to the bacteria via contaminated medical products including ventilators or iv catheters; person-to-person by Read More

July 11, 2016: Alere to Initiate Withdrawal of the Faulty Blood-Thinner Monitor

Faulty Blood-Thinner Monitor Announcement Regarding Faulty Blood-Thinner Monitor Alere Inc. will be withdrawing from the market the blood-thinner monitor, Alere INRatio® and INRatio®2 PT/INR Monitoring System, because the device may potentially show inaccurate results. OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION If you are a loved one has been seriously injured by a medical device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form” found on this page, or contact us toll free at 1-877-934-6274 for a free legal case evaluation. Blood-Thinner Monitor This product is used to measure levels of blood-thinning medicines in the user. Blood-thinning medications are used to slow blood clotting, preventing complications like blood clots forming on artificial valves, valve obstruction and blood clots traveling to the brain and causing stroke. In association with the U.S. Food and Read More

June 29, 2016: HeartWare Faulty Battery in Ventricular Assist Device Recalls

HeartWare Faulty Battery ISSUE: HeartWare Inc. has issued a recall of the batteries to their Ventricular Assist Device because these batteries contain faulty cells that may cause the device to lose power prematurely. The FDA provided the following information in a June 29, 2016 News Release. If the battery of the HeartWare Ventricular Assist Device system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death BACKGROUND: The HeartWare Ventricular Assist Device is used to deliver blood from the heart to the rest of the body in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted Read More

June 13, 2016: FDA Updates Previous Warning to Express Zecuity Patch Scar Burn Recall

Zecuity Patch Scar Burn Recall On June 1, 2016, the U.S. Food and Drug Administration (FDA) reported the possible risk of serious burns and potential permanent scarring associated with the use of the migraine headache treatment device, the Zecuity patch. June 13, 2016 Zecuity Patch Scar Burn Update Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. To see our original June 2, 2016 FDA Safety Communication article, visit Zecuity Patch Scar Burn Risk. Many Reports Affirm Zecuity Patch Scar Burns In September 2015, as marketing of the Zecuity patch began, a large number of patients reportedly suffered burns Read More

June 3, 2016: Six-Year Study of Hemophilia Treatments in Toddler Patients Concludes

After five years of research, a study, called the SIPPET (Survey of Inhibitors in Plasma-Products Exposed Toddlers), has released the first findings as to whether hemophilia treatments sourced from human plasma may be safer for hemophiliac toddlers than treatments sourced from genetic engineering. What is Hemophilia? Hemophilia is an inherited bleeding disorder characterized by the body’s inability to form blood clots. This occurs due to an absence or low levels of either factor VIII (referred to as hemophilia A) or factor IX (referred to as hemophilia B) clotting proteins that are found in the blood. As a result, a person with hemophilia may experience spontaneous bleeding, or prolonged bleeding following an injury. The condition cannot be cured. The severity of hemophilia is categorized as mild, moderate, or severe; and is based on the levels of clotting proteins found in a Read More

June 3, 2016: Letter Reveals Negligence Behind the Pasadena Hospital Duodenoscope Superbug Outbreak

Pasadena Hospital Duodenoscope Superbug Outbreak One hospital in California which had suffered a duodenoscope superbug outbreak released a letter revealing the hospital’s own negligence in reporting the outbreak. Huntington Hospital in Pasadena, California broke state law by not quickly reporting a suspected deadly outbreak last year. The duodenoscope superbug outbreak sickened 16 patients, 11 of whom died, from the first patient case in January 2013 to August 2015. Duodenoscope Infection Lawsuit Help The Law Firm of Eric H. Weinberg is assisting individuals nationwide who may have suffered an infection following an endoscopic procedure known as ERCP. Since 1984, Attorney Weinberg has represented personal injury victims, including those injured by defective medical devices, including metal-on-metal hip joints, transvaginal mesh, and apnea monitors. For a free legal case evaluation, please call our law firm toll free at 1-877-934-6274. . Pasadena Hospital Duodenoscope Read More

June 2, 2016: FDA Cautions Public of The Zecuity Patch Scar Burn Risk

Zecuity Patch Scar Burn Risk On June 1, 2016, the U.S. Food and Drug Administration (FDA) reported the possible risk of serious burns and potential permanent scarring associated with the use of the migraine headache treatment device, the Zecuity patch. Many Reports Affirm Zecuity Patch Scar Burn Risk In September 2015, as marketing of the Zecuity patch began, a large number of patients reportedly suffered burns or scars on the skin where the patch was worn, including descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. The Zecuity Patch Scar Burn Risk The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or Read More

June 1, 2016: FDA Warns of Association of Bacterial Infections Heater-Cooler System

Bacterial Infections Heater-Cooler System The FDA issued a Safety Communication informing the public and health professionals of the potential threat of M. chimaera bacterial infections associated with the use of heater-cooler systems in patients who have undergone cardiothoracic surgeries. Heater-Cooler System Details Heater-cooler systems are commonly used to provide heated and/or cooled water to oxygenator heat exchangers, and cardioplegia (paralysis of the heart) heat exchangers, to warm or cool a patient’s blood during cardiac surgical procedures, and in warming/cooling blankets. Danger of Bacterial Infections Heater-Cooler System Association Heater-cooler system work by distributing temperature-controlled water from a water tank to the exchanger or blanket. The concern with this design is that sometimes, if used improperly, contaminated water may seep into other parts of the device and spread bacteria to the patient, or escape from the device’s exhaust vent into the air Read More

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