Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to PatientsFebruary 24, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments
Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration.
CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short CircuitFebruary 23, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments
Affects device and software that aids in the identification and mapping of areas of the brain.
Reports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.
Updates to sorbent hemoperfusion system, cardiovascular permanent pacemaker electrode, CES, external pacemaker pulse generator, implantable pacemaker pulse generator, pacemaker programmers
Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious InjuriesFebruary 16, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments
Brush head may break off in the user's mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes.
Public Workshop - Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act, March 7, 2012February 16, 2012 5:32 am | by U.S. Food & Drug Administration | News | Comments
This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies. The purpose of the workshop is to provide a forum for...
FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered ToothbrushesFebruary 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA is aware of reports of serious injuries and potential hazards associated with the use of the Spinbrush. These reports indicated that while turned on, the brush head has either ?popped off? or broken off in the user?s mouth or near the face...
The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy: Class I Recall - Humidifier Lids Fail to Pop Off at the Intended PressureFebruary 14, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments
The humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.
Product marketed as dietary supplement contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (March 23, 2012)February 12, 2012 11:31 pm | by U.S. Food & Drug Administration | News | Comments
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or EffectiveFebruary 10, 2012 5:31 pm | by U.S. Food & Drug Administration | News | Comments
Products could potentially expose users and patients to unnecessary and potentially harmful X-rays.
Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.
Smith & Nephew has agreed to pay the U.S. government $22.2 million to settle allegations it bribed Greek doctors to encourage the use of its orthopedic products.
The device industry and congressional allies are considering using the Medical Device User Fee Act (MDUFA) reauthorization package or other legislation as a vehicle to repeal the medical device tax before it can take effect in January 2013.
The Gastroenterology-Urology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology and nephrology devices...
Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs: Drug Safety Communication - Drug InteractionsFebruary 9, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments
Interactions between Victrelis and ritonavir-boosted atazanavir, lopinavir, and darunavir can potentially reduce the effectiveness of these medicines when co-administered.
SAN JOSE, Calif.--(BUSINESS WIRE)--Alverix announced today that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritorâ„¢ System Flu A+B Test. The BD Veritor System was developed...
AUSTIN, Tex.-Despite a tepid economy, medical device manufacturers' international sales growth rates continued to outpace their domestic business in 2011, demonstrating the increasingly global nature of the industry. According to a new survey of more than 2,600 medical device industry...
Survey: Smaller Medical Device Firms Plan to Increase Prices and Lower Costs to Offset US Excise TaxFebruary 9, 2012 4:34 am | News | Comments
AUSTIN, Tex.-According to a new industry survey conducted by global consultancy Emergo Group, medical device manufacturers plan to increase prices for their products in order to offset the effects of a proposed 2.3% excise tax on all device sales in the US set to take effect in 2013.
Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid DrugsFebruary 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
Symptoms may include watery stool, abdominal pain, and fever. Patients may go on to develop more serious intestinal conditions.
The Neurological Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics ...
GAO Investigation Finds Lack of Price Transparency in Medical Device Marketplace May Drive up Costs for Hospitals and MedicareFebruary 6, 2012 5:47 am | News | Comments
Washington, DC â€“ The Healthcare Supply Chain Association (HSCA) today applauded the U.S. Government Accountability Office for its new report, Lack of Price Transparency May Hamper Hospitals' Ability to Be Prudent Purchasers of Implantable Medical Devices, which found that...
Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.