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Safety tips for intense pulsed light therapy

March 1, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

Article 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...

Statin Drugs - Drug Safety Communication: Class Labeling Change

February 28, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

New adverse event and liver enzyme monitoring information in statin labels and updated drug interactions information in lovastatin label.

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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 | 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.

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 | Comments

Women 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 | Comments

Proposed 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 | Comments

Johnson & 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 | Comments

Doors and drawers may inadvertently open while bassinet is in motion; product may be difficult to maneuver due to it swivel caster configuration.

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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 | Comments

Affects 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 | Comments

Reports 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 | Comments

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 Injuries

February 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, 2012

February 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...

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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 | 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...

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

February 14, 2012 5:32 pm | by U.S. Food & Drug Administration | News | Comments

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 Pressure

February 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.

RegenArouse: Recall - Undeclared Drug Ingredient

February 13, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

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 Effective

February 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.

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 | Comments

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.

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 | Comments

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.

Battle Heats Up for Repeal of Device Tax; Language May Be MDUFA Rider

February 10, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

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.

Transcripts of January 11, 2012 Gastroenterology-Urology Devices Panel Meeting

February 10, 2012 4:31 am | by U.S. Food & Drug Administration | News | Comments

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 Interactions

February 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.

BD Veritor System for Flu A+B Featuring Alverix Technology Receives Regulatory Approval in Japan

February 9, 2012 5:02 am | News | Comments

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...

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