Archive > January 2010

635,000 cribs recalled for risk to infants

admin » 29 January 2010 » In Defective Products » No Comments

dorel_asia_cribs.03

635,000 cribs recalled for risk to infants

About 635,000 cribs sold at major discounters nationwide have been recalled by Dorel Asia SRL for strangulation and suffocation hazards that killed one child and injured 10 others, the government said Tuesday.

The U.S. Consumer Product Safety Commission said that the hardware holding up the side of the crib can fail, causing the drop side of the crib to detach, which could trap and suffocate a child.

The drop side is “the side of the crib that caregivers can move up and down to get a child in or out of the crib,” said Kim Dulic, a spokeswoman for the CPSC.

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Huber Needles Recalled

admin » 28 January 2010 » In Defective Products, FDA » No Comments

Huber Needles Recalled

DA Announces Class I Recall of Certain Infusion Set Needles
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers:

Exel/Exelint Huber Needles Product Codes/Catalog Numbers
26901
26902
26904
26906
26907
26908
26909
26911
26921
26922
26923
26924
26925

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Apple unveils the iPad – at last – and it’s $499

admin » 27 January 2010 » In Tech News » No Comments

IpadApple unveils the iPad – at last – and it’s $499

All the naysayers can feel free to eat their hats. Today Apple finally revealed the device we’ve all been whispering about for a good year or more. The Sasquatch of gadgets is real. We’ll update this with all the details as they happen; in the meantime, follow our live coverage.

Looks like a big iPhone to us.

* 1GHz Apple A4 processor (custom)
* 0.5″ thick
* 1.5 pounds
* 9.7″ Capacitive touchscreen (1024×768)
* 16-64GB of SSD storage
* 3G available but not in all iPads
* $14.99 for 250MB, $29.99 for unlimited data on AT&T (no contract)
* 3G iPads are unlocked, have GSM micro SIMs
* Accelerometer, Compass
* 802.11n and Bluetooth 2.1
* Runs iPhone apps in window or pixel doubling
* Hardware-accelerated OpenGL graphics
* SDK out today
* $499 for 16GB base model, $830 for all maxed out
* Dock with hard keyboard available

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FDA letters cite Lilly, Bayer, Amylin and Cephalon Bayer

admin » 18 January 2010 » In FDA » No Comments

FDA letters cite Lilly, Bayer, Amylin and Cephalon Bayer

Federal health regulators have issued enforcement letters to Eli Lilly, Bayer, Amylin Pharmaceuticals and Cephalon for making inaccurate or incomplete statements while promoting their drugs.

The Food and Drug Administration on Tuesday disclosed four letters issued to the companies by its marketing enforcement division.

The letter to Lilly cites a print advertisement for the antidepressant Cymbalta, which is approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia. According to the FDA, Lilly’s ad did not adequately display information about the drug’s side effects, a requirement for all pharmaceutical promotions.

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ATRA’s “Hellholes”: Bankrolled by Insurance, Tobacco, Big Pharma

admin » 11 January 2010 » In Legal News » No Comments

ATRA’s “Hellholes”: Bankrolled by Insurance, Tobacco, Big Pharma

The American Tort Reform Association (ATRA) today peddled its debunked and recycled “Hellholes” annual report – an effort bankrolled by insurance, tobacco, and drug companies to attack the civil justice system and gain complete immunity for their negligent behavior.

“For years, the most deceitful and predatory corporations have used front groups like ATRA to prevent everyday Americans from receiving justice,” said American Association for Justice Communications Director Ray De Lorenzi. “As our country emerges from this current financial crisis, people realize more than ever why a strong civil justice system is needed to hold wrongdoers accountable. ATRA’s report is yet another indication that corporations will say or do anything to weaken Americans’ basic legal protections.”

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FDA Yet to Institute Post-Vioxx Recommendations

admin » 02 January 2010 » In FDA » No Comments

FDA Yet to Institute Post-Vioxx Recommendations

The Food and Drug Administration still hasn’t restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal.

That’s according to congressional investigators who found that the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the embarrassing and dangerous episode with Vioxx, a blockbuster pain drug the FDA approved in 1999, only to pull from the market in 2004 after linking it to heart attack and stroke.

Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market.

“It is not yet clear if or when FDA’s decision-making process will be substantially improved as a result of its efforts,” according to the GAO report, a copy of which was obtained by The Associated Press.

Within the FDA bureaucracy, scientists tasked with reviewing new drug applications have traditionally had the most say over questions of safety, even after drugs are approved. But outside experts say leaving such key decisions to the scientists who first cleared the drugs could lead to inadequate safety actions, putting prescription drug users at risk.

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