Recalls in September 2010

There have been 10 reports of incidents resulting in injury. Six of the incidents required medical attention after young girls, ages two to three years old, fell against or on the protruding disc-shaped and D-shaped pretend key.

This recall involves the Fisher-Price Trikes and Tough Trikes toddler tricycles with model numbers listed in the chart below and that have either a disc-shaped or D-shaped pretend key. The model numbers are located under the seat in the storage compartment. The trikes are intended for children 2 to 5 years of age.

The pretend keys are located about 3 inches in front of the seat and protrude at least 5/8 inches above the trike's body. The trikes manufactured after June 16, 2010 are not included in this recall. These trikes have a modified key in a flattened D shape (see picture below) and a manufacturer run number higher than 1670Q2. The run number indicates the trike was manufactured on the 167th day of 2010 or on June 16, 2010. The run number is found under the seat below the model number.

The trikes were sold at mass merchandise stores nationwide from January 1997 through September 2010 for about $25.

Consumers should immediately place the trikes out of children's reach and contact Fisher-Price for a free replacement key.

For additional information, contact Fisher-Price at (800) 432-5437 between 9 a.m. and 6 p.m. ET Monday through Friday or visit the firm's website at www.service.mattel.com.

The recalled products are: Baby Playzone Crawl & Cruise Playground, Baby Playzone Crawl & Slide Arcade, Baby Gymtastics Play Wall, Ocean Wonders Kick & Crawl Aquarium (C3068 and H8094), 1-2-3 Tetherball, Bat & Score Goal

There have been 46 reports of incidents where the valve came off in the US and eight reports in Canada. These include 14 reports of the valve found in a child's mouth and three reports of a child beginning to choke. No injuries have been reported.

This recall involves the products listed below:

Consumers should immediately remove the inflatable ball from the product and keep away from children. Do not discard the inflatable ball. Contact Fisher-Price for a free replacement kit.

For additional information, contact Fisher-Price at (800) 432-5437 between 9 a.m. and 6 p.m. ET Monday through Friday or visit the firm's website at www.service.mattel.com

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

There have been 14 reports of incidents, including seven reports of children requiring stitches and one tooth injury.

This recall involves the Healthy Care, Easy Clean and Close to Me High Chairs with pegs on the back legs intended for tray storage. The high chairs have a folding frame for storage and a three-position reclining seat. The model number and date code of the high chair is on the back of the seat.

All Easy Clean and Close To Me High Chairs are included in this recall. Only Healthy Care High Chairs manufactured before December 2006 are included in the recall. If the fourth digit in the date code is 6 or less, the Healthy Care High Chair is included in the recall.

The chairs were sold at mass merchandise retail stores nationwide from September 2001 through September 2010 for between about $70 and $115.

Consumers should stop using the High Chair immediately and contact Fisher-Price for instructions and a free repair kit.

For additional information, contact Fisher-Price at (800) 432-5437 between 9 a.m. and 6 p.m. ET Monday through Friday or visit the firm's website at www.service.mattel.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

There have been two reports of a wheel detaching from a vehicle. No injuries have been reported.

The recall involves Little People Wheelies Stand 'n Play Rampway with model numbers T4261 and V6378. They were sold with small cars that a child can push down winding ramps. Only the purple and the green cars that are marked "Mexico" and do not have a yellow dot on the bottom are included in the recall. The toy is intended for children 1 1/2 to 5 years of age.

The toys were sold at mass merchandise stores nationwide from April 2010 through September 2010 for about $45.

Consumers should immediately take the affected purple and the green cars away from children and contact Fisher-Price for free replacement cars.

For additional information, contact Fisher-Price at (800) 432-5437 between 9 a.m. and 6 p.m. ET Monday through Friday or visit the firm's website at www.service.mattel.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

Perhaps. Doctors report more patients complaining of tingling, numbness and pain in their fingers and wrists. Is it just tired hands or something more serious?

Since this is a relatively recent complaint, at least in large numbers, physicians are looking around for a recent phenomenon that might explain it. Their attention quickly fell on texting.

152.7 billion texts

With over 152.7 billion text messages sent per month in the United States alone, it is becoming clear that people are shifting their primary method of communication from voices to hands and fingers. Does this shift explain the injuries?

While these complaints can all be signs of tired, overused hands, these symptoms can also indicate something more serious, such as a repetitive stress injury, tendonitis, aggravation of arthritis or sprains, and even carpal tunnel syndrome, doctors say.

It is important that patients dont dismiss symptoms of sore fingers, occasional numbness and tingling, says George Kardashian, M.D., an orthopedic surgeon and hand specialist at The Center for Bone and Joint Disease in Hudson, FL. These symptoms are all the bodys way of saying it needs a break or a more serious injury will occur.

Interestingly, despite the common conception that typing and texting cause carpal tunnel; there is no scientific evidence proving that keyboard use leads to carpal tunnel. That is why it is so important for people to go see their doctors when experiencing symptoms in their hands and wrists, instead of trying to self-diagnose.

How to Prevent Serious Injuries

Since it is almost impossible to stop using mobile devices or computers completely, it is important to know how to prevent these symptoms from turning from sore, tired fingers into something more severe.

Kardashian suggests patients take frequent breaks from texting and typing and stretch the affected areas if experiencing any symptoms. If pain and/or swelling exist, use ice packs to reduce swelling while giving your hands a rest. Also, for those individuals who spend most of their day in front of a computer it is important to have an ergonomic workstation.

Be aware of the additional strain you are putting on your hands, fingers, thumbs and wrists, Kardashian said. Taking precautions by stretching and resting your hands and wrists will allow your body to recover.

Aron Culotta, assistant professor of computer science at Southeastern Louisiana University, has found that keeping track of influenza outbreaks has the potential to be far quicker and less costly by monitoring a social network program such as Twitter than following the traditional methods of disease surveillance.

A process called syndromic surveillance uses collected health-related data to alert health officials to the probability of an outbreak of disease, typically influenza or other contagious diseases. The technique involves collecting data from hospitals, clinics and other sources, a labor-intensive and time consuming approach.

By monitoring a social network such as Twitter, researchers can capture comments from people with the flu who are sending out status messages.

A micro-blogging service such as Twitter is a promising new data source for Internet-based surveillance because of the volume of messages, their frequency and public availability, Culotta said. This approach is much cheaper and faster than having thousands of hospitals and health care providers fill out forms each week.

The Centers for Disease Control produces weekly estimates, he notes ut those reports typically lag a week or two behind.

This approach produces estimates daily, Culotta said.

500 million Tweets

Culotta and two student assistants analyzed more than 500 million Twitter messages over the eight-month period of August 2009 to May 2010, collected using Twitters application programming interface (API). By using a small number of keywords to track rates of influenza-related messages on Twitter, the team was able to forecast future influenza rates.

Once the program is running, its actually neither time consuming nor expensive, he said. Its entirely automated because were running software that samples each days messages, analyzes them and produces an estimate of the current proportion of people with the flu.

Southeasterns group obtained a 95 percent correlation with the national health statistics collected by the CDC. In addition, the results were comparable to figures collected by Google with its Flu Trends service, which tracks influenza rates by analyzing trends in query terms.

Culotta said the statistics he collected were for the whole country. His future work will look at extracting information from messages that include more location-specific data. This would allow him to more easily segment reporting information by regions. He is also planning a Web site that will display his results in real time, being developed in collaboration with graduate student Matthew Gill and computer science senior Ross Murray.

The Twitter advantage

Culotta said using Twitter has an advantage over Google because the high message and posting frequency of Twitter enables up-to-the minute analysis of an outbreak. Twitter, he said, reports having more than 105 million users posting nearly 65 million messages a day. Approximately 300,000 new users are added daily.

Despite the fact that Twitter appears targeted to a young demographic, it does in fact have quite a diverse set of users, he said. The majority of Twitters nearly 10 million unique visitors in February 2009 were over 35 years old, and a nearly equal percentage of users are between the ages 55 and 64 as between 18 and 24.

This recall involves Quickie Shark bikes with custom footrests that are designed for use by disabled persons. Model numbers included in the recall are SB472900001 and SB471900001. Model and serials numbers are printed on the right side of the bike frame. Serial numbers included in the recall are: KS910634, KS933266, KS935245, KF130177, KF130177, KF138342, KF157355, KF182230, KF214063, KF214095, KF228670, KF230678, KF268500, KF271632, KF275166, KF341126, KF344298 and KF370981.

The bikes, made in Germany, were sold by Sunrise Medical authorized dealers nationwide from March 2007 through October 2009 for about $4,300.

Consumers should immediately stop using the bikes and contact Sunrise Medical or their Sunrise Medical dealer for instructions on how to obtain replacement footrests.

For more information, contact Sunrise Medical at (888) 208-4901 anytime, or visit the firm's website at www.sunrisemedical.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

Molenaar LLC is recalling about 315,000 Electroluminescent night lights. The night lights can become hot to the touch and melt, resulting in risk of possible shock or fire.

The firm is aware of 4 incidents of the night lights melting, resulting in minor property damage. No injuries have been reported.

Two models of the night lights are being recalled. One model, Model No. 2019, is shaped like a house. The other, Model No. 2017, is square-shaped with a rounded top. The night lights glow green when plugged into an electrical outlet. 71980 U.S.A. is molded into the night lights back panel, just above the brass outlet prongs. The night lights may have the brand names or logos of various companies printed on the front.

The recalled night lights were distributed free as promotional products by various companies imprinted with various company names between October 2001 and November 2009. They were made in the U.S.

Consumers should immediately stop using the recalled night lights and throw them away.

For additional information, contact Molenaar at (877) 719-4442 between 7 a.m. and 5 p.m. CT Monday through Friday or visit the firms website at www.miline.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

The recalled circuit breakers have a spring clip that can break during normal use, leading to a loss of force to maintain a proper electrical connection in the panelboard. This can lead to excessive temperature, arcing or thermal damage at the connection point, and damage to the panelboards electrical insulation and can result in a fire, property damage, or personal injury.

Siemens has received one report of a circuit breaker spring clip that broke during installation. No injuries have been reported.

This recall involves Siemens and Murray 15 through 50 AMP single and double pole circuit breakers, load centers (circuit breakers that come with an electrical panel), and meter combos (contain a load center and a meter socket). Siemens or Murray, date codes 0610 or 0710 and the catalog number are printed on a label on the side of the circuit breakers. Date codes between June 2010 through August 2010 are stamped on the inside of the metal box of the load centers and meter combos. The catalog number for the load centers and meter combos is printed on a label inside the metal box door and on the packaging.

The items were sold at The Home Depot, Lowes, other hardware and building supply stores and numerous electrical distributors nationwide from June 2010 through August 2010 for between $2.50 to $235. They were made in Mexico.

Consumers should immediately contact Siemens for a free inspection by an electrician and a free replacement product.

For additional information, contact Siemens at (800) 756-6996 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the firms website at www.usa.siemens.com

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

Black & Decker has received 34 reports of the motor operating after removal of the safety key, including two incidents that resulted in finger lacerations, one requiring stitches.

The recalled cordless electric mowers were sold under both the Black & Decker and Craftsman brand names. The recalled Black & Decker mowers have model number CMM1000 or CMM1000R. All date codes and types are included. The date code and type information are both located on a silver and black label affixed to the rear door of the mower. The Black & Decker mowers have either an orange or green deck with a black motor cover. The Craftsman-brand mowers have model number 900.370520 and include all date codes and types. The model number is located on the silver and black label affixed to the rear door of the mower. The Craftsman-brand mowers have a dark green deck with a black motor cover.

The lawnmowers were sold at home center, hardware and discount stores and authorized Black & Decker dealers nationwide from September 1995 through December 2006 for about $450. Craftsman-brand mowers were sold at Sears and Orchard Supply Hardware stores nationwide from January 1998 through December 2000 for about $450.

Consumers should stop using the recalled lawnmowers immediately and call Black & Decker or Sears for a free inspection and repair, or a credit towards a new cordless lawnmower. Consumers who had their mowers repaired as a result of the previous recalls should also have their mowers inspected and repaired as part of this recall.

For additional information, consumers with Black & Decker mowers should contact Black & Decker toll-free at (866) 229-5570 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firms website at www.blackanddecker.com. Consumers with Craftsman-brand mowers should call Sears toll-free at (888) 281-5314 between 7 a.m. and 9 p.m. CT Monday through Saturday or visit the firms website at www.sears.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).

These claims suggest the products are effective in preventing gum disease when the FDA contends no such benefit has been demonstrated.

Warning letters were sent to Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash) and Walgreen Company (Walgreen Mouth Rinse Full Action).

Lack of evidence

These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

"It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research.

Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.

The FDA actions are part of the agency's effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.

To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.

Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days. Failure to do so may result in seizure of the product, or other civil or criminal penalties.

The joint federal and state investigation alleged that AstraZeneca engaged in a pattern of unlawful marketing activity, including "off-label" marketing and kickbacks to promote and sell Seroquel.

Off-label marketing involves promoting a drug for uses that have not been approved by the U.S. Food and Drug Administration (FDA). While it is not illegal for a physician to prescribe a drug for an unapproved use, federal law prohibits a manufacturer from promoting a drug for uses not approved by the FDA.

According to the settlement, from Jan. 1, 2001 through Dec. 31, 2006, AstraZeneca promoted the sale and use of Seroquel for certain uses that the Food and Drug Administration (FDA) had not approved.

The settlement also resolves allegations that the companys promotional activities were directed not only to psychiatrists but to primary care physicians and other health care professionals for unapproved uses in treatment of medical conditions such as aggression, Alzheimers disease, anger management, anxiety, attention deficit hyperactivity disorder, dementia and sleeplessness.

Additionally, AstraZeneca allegedly paid illegal kickbacks to doctors, including gifts, and complimentary visits to resort locations to advise AstraZeneca about marketing messages and articles, and to conduct studies for unapproved uses of Seroquel. Federal law prohibits payment of anything of value in exchange for prescribing a product paid for by a federal health care program.

The settlement also resolves claims that, as a result of their promotional activities, AstraZeneca caused physicians to prescribe Seroquel for children, adolescents and dementia patients in long term care facilities.

As part of the settlement, AstraZeneca is required to enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the companys future marketing and sales practices

Salmonella enterica -- a common cause of food poisoning -- exploits the immune response in the human gut to enhance its own survival.

Salmonella strategy

The strategy, which improves reproductive and transmission success, gives Salmonella a growth advantage over the beneficial bacteria that normally are present in the intestinal tract, researchers report in the journal Nature. This advantage promotes the severe diarrhea that spreads the bacteria to other people.

"The human body normally has 10 times more microbes than human cells that help protect us against infection from disease-causing bacteria," says Andreas Baumler, professor of medical microbiology and immunology at the University of California, Davis, and the study's principal investigator. "We have discovered Salmonella's cunning trick that allows it to quickly take over and outgrow the beneficial microbes in our intestine."

All bacteria must generate energy in order to live and reproduce, either by respiration -- which usually requires oxygen -- or fermentation.

Because essentially no oxygen is available in our intestines, the beneficial bacteria that reside there tend to use fermentation, which is less efficient than respiration for obtaining energy.

When people ingest Salmonella, it invades the surface of the intestine. Our immune system responds by producing oxygen radicals to kill the bacteria.

Surprising discovery

Although some Salmonella bacteria are killed by this response, many more benefit: the oxygen radicals create a sulfur compound called tetrathionate, which Salmonella are able to use instead of oxygen for respiration.

Interestingly, tetrathionate has been used since 1923 by microbiologists as a way to promote the growth of Salmonella in biological samples containing competing microbes.

But because tetrathionate was not known to exist in living people, it was assumed prior to this study that this process had little relevance for food poisoning.

Up until now, tetrathionate was believed to mainly exist naturally in decaying corpses or in thermal springs.

"Stimulating the host to produce tetrathionate enables Salmonella to 'breathe' in the intestine," says Sebastian Winter, who is a member of Baumler's laboratory and lead author of the article. "This gives Salmonella a tremendous advantage over the gut bacteria that must grow by fermentation."

By stimulating an inflammatory response in the intestine, Salmonella also enhances its transmission to other hosts. The inflammatory response causes the severe diarrhea and vomiting that is the body's attempt to rid itself of the pathogenic bacteria, at the same time enabling Salmonella's spread.

"Determining how Salmonella is so efficient in outcompeting resident beneficial bacteria is a critical first step in developing new drugs for treating food poisoning," says Baumler, whose group is now pursuing this avenue of research. "We are hopeful that by targeting sulfur compounds we can stop the bacteria from establishing a foothold in the intestine."

Additional researchers at UC Davis and Texas A&M University contributed to the work, which was funded by Public Health Service grants.

The folate, levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz, manufactured by Bayer, is based on the approved product YAZ, which contains the same doses of estrogen and progestin, and is approved for:

• Prevention of pregnancy
• Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
• Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.

In addition to the approved YAZ indications, Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

The most common side effects reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches. Other serious side effects include vascular events (blood clots) and liver disease. Women over age 35 who smoke should not use this product as cigarette smoking increases further the risk of serious cardiovascular events.

The common adverse events for Beyaz are expected to be the same as those for YAZ. There were no findings from the clinical trials with Beyaz to suggest a change in the overall safety profile compared to that of YAZ.

Perhaps the most eagerly-awaited is the provision that insurance companies may no longer exclude children from health insurance policies because of pre-existing conditions. The White House says there are 72,000 uninsured children -- many with serious chronic illnesses -- who are eligible for coverage as of today.

Other new protections taking effect today:

• Children up to age 26 may now be included on their parents' health insurance policies;

• Insurers may no longer impose lifetime limits on benefits;

• Insurers may no longer drop sick customers afer "discovering" previously-undetected mistakes on their applications;

• Preventive measures like colonoscopies, mammograms and immunizations must now be covered without a co-pay;

• Consumers who join a new health plan may keep their own doctors;

• Insurance companies reimbursement decisions may now be appealed to a third party;

• Small businesses may become eligible for tax credits that make it easier for them to provide coverage to their employees;

• Early retirees, ages 55-64, may be eligible to participate in the Early Retiree Reinsurance Program;

• Seniors who fall into the prescription "donut hole" will receive $250 rebate checks.

President Obama marked the occasion yesterday by paying a visit to a Falls Church, Va., couple, holding a "backyard summit" with Paul and Frances Brayshaw and their neighbors.

Obama said that prior to the law's passage, American families faced "horrendous" vulnerability if they became sick or lost their insurance coverage. He said the new measure gives families "some basic peace of mind."

Despite widespread political posturing and calls for the law's repeal, polls have generally found many of its provisions popular, particularly among the 14 million Americans who must now buy their insurance on the open market because they are not covered on a group health plan.

Read more about Health Care Reform.

September 23, 2010
Inconsistent use of a simple, reliable test to screen for early colorectal cancer may be compromising the tool's effectiveness in reducing death rates from the disease.

A new study finds that many patients who initiate stool blood testing do not complete subsequent screenings as recommended by screening guidelines.

Stool testing to detect microscopic amounts of blood has been endorsed worldwide for adults 50 and older. Trials have found that when performed annually or every other year, the test reduces colorectal cancer incidence and mortality by 33 percent.

Cost-effective tool

In the United States, colonoscopy is used more widely to screen for the disease, but stool blood testing -- at less than $25 per test -- is considered the more cost-effective method and is the key screening strategy for many health plans and for underserved and rural populations.

"Many patient and providers may not realize that this test needs to be repeated regularly to yield benefits, just like mammograms or Pap smears for women," says Joshua Fenton, assistant professor of family and community medicine at University of California at Davis.

Fenton and colleagues examined records of 11,000 patients enrolled in Group Health, a health plan based in Seattle, who had a stool blood test within a two-year period.

Follow-up on those patients found that nearly 50 percent did not repeat the test within the next two years, as recommended. Another eight percent had a different type of screening, such as sigmoidoscopy or colonoscopy.

Details of the study, which was funded by the National Cancer Institute and American Cancer Society Mentored Research Scholars Grant and by an HMO Cancer Research Network pilot grant, are published in the September/October issue of the journal Annals of Family Medicine.

This recall involves a mood necklace which is 18 inches in length and an adjustable ring. The products change colors when the user's "mood" changes. "Love Tester" and "Are You In the Mood" are labeled on the products' packaging. The products are sold separately.

The rings and necklaces, made in China, were sold by small retail stores nationwide from September 2005 through June 2010 for about $4.

Consumers should immediately take the recalled jewelry away from children and return to the store where purchased to receive a full refund or replacement product.

For additional information, contact D&D Distributing-Wholesale at (800) 262-9435 between 9 a.m. and 5 p.m. PT Monday through Friday or visit the firm's website at www.dddist.com.

The recall is being conducted in cooperation with the U.S. Consumer Product Safety Commission (CPSC).