Archive for April, 2010
The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.
Tags: fda press release
UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
Tags: MedWatch Safety Alerts
About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today.
Tags: fda press release
The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010.
Tags: fda press release
Two Arrests Made in Contaminated Food Case
Tags: fda press release
Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.
Tags: MedWatch Safety Alerts
Covidien (NYSE: COV) has initiated a voluntary recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal.
Tags: FDA Recalls
The U.S. Food and Drug Administration today announced a new initiative to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner.
Tags: fda press release
Class I Recall issued because of the potential for the device to expectedly
power off and/or power on.
Tags: MedWatch Safety Alerts
April 20, 2010: Buckley Woman Sentenced to Jail Time, Home Detention for False Claim of Glass in Bottled Water
Tags: fda press release