Medical Design Technology
Consumer Information on: OVATION Abdominal Stent Graft System - H100008
March 5, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...
March 2, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsUnexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.
Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators - AEDs
March 2, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsThe affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences
Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle Injury
March 1, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsProtease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.
Safety tips for intense pulsed light therapy
March 1, 2012 4:31 am | by U.S. Food & Drug Administration | News | CommentsArticle originally published in Nursing2012, February issue. DEVICE SAFETY INTENSE PULSED LIGHT (IPL) therapy is indicated for use in surgical, aesthetic, and cosmetic applications. IPLs use flashlamps, computercontrolled power supplies, and bandpass...
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly
February 28, 2012 10:31 am | by U.S. Food & Drug Administration | News | CommentsCustomers should stop using the alarm cable
Statin Drugs - Drug Safety Communication: Class Labeling Change
February 28, 2012 8:30 am | by U.S. Food & Drug Administration | News | CommentsNew adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label.
Radiological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (April 11-12, 2012)
February 28, 2012 3:31 am | by U.S. Food & Drug Administration | News | CommentsThis 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.
Norgestimate and Ethinyl Estradiol Tablets: Recall - Packaging Error, Potential for Incorrect Dosing Regimen
February 27, 2012 3:30 am | by U.S. Food & Drug Administration | News | CommentsWomen may be left without adequate contraception, and at risk for unintended pregnancy.
Industry to CMS: Accuracy, Clarity of Sunshine Act Provisions Needed
February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | CommentsProposed Sunshine Act provisions for documenting devicemaker payments to physicians need more context and clarity, industry members say.
J & #38;J Taps Devices Unit Head to Replace Beleaguered CEO
February 24, 2012 1:30 pm | by U.S. Food & Drug Administration | News | CommentsJohnson & Johnson’s (J&J) upcoming CEO switch, from Bill Weldon to devices business head Alex Gorsky, could signal the company’s confidence in its ongoing relaunch of McNeil Consumer Products, an analyst says.
Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients
February 24, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsDoors 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 Circuit
February 23, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsAffects device and software that aids in the identification and mapping of areas of the brain.
Infants' TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints(2)
February 17, 2012 11:32 am | by U.S. Food & Drug Administration | News | CommentsReports of dosing syringe flow restrictor being pushed into the bottle when inserting the syringe.
CDRH Transparency: 515 Program Initiative Status Update
February 17, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsUpdates 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 Injuries
February 16, 2012 10:31 am | by U.S. Food & Drug Administration | News | CommentsBrush 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, 2012
February 16, 2012 5:32 am | by U.S. Food & Drug Administration | News | CommentsThis 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 Toothbrushes
February 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe 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...
Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices
February 14, 2012 5:32 pm | by U.S. Food & Drug Administration | News | CommentsThe 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 Pressure
February 14, 2012 4:31 am | by U.S. Food & Drug Administration | News | CommentsThe humidifier can leak and can potentially interrupt the flow of supplemental oxygen to the patient.
RegenArouse: Recall - Undeclared Drug Ingredient
February 13, 2012 3:30 am | by U.S. Food & Drug Administration | News | CommentsProduct 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 | CommentsThis 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 Effective
February 10, 2012 5:31 pm | by U.S. Food & Drug Administration | News | CommentsProducts could potentially expose users and patients to unnecessary and potentially harmful X-rays.
Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall - Non-Sterile Products
February 10, 2012 5:31 pm | by U.S. Food & Drug Administration | News | CommentsProducts 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.
S & #38;N Pays $22.2 Million to Settle Foreign Bribery Charges
February 10, 2012 1:31 pm | by U.S. Food & Drug Administration | News | CommentsSmith & 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.
