InjuryBoard National News Desk

Death of the Drop-Side Crib Following Recall

Jane Akre — Tue, 24 Nov 2009 11:14:03 GMT

CPSC Not Acting Quickly Enough

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CPSC - Public Safety notice Stork Craft Cribs
Stork Craft Manufacturing of Canada - 877-274-0277
IB News - Crib Recall Part 2 - Chicago Tribune Investigation Prompts Recall - October 2007
IB News - Recalled Simplicity Bassinet After Two Infants Strangled - August 2008
Consumer Product Safety Improvement Act of 2008
IB Partner- John Cooper, Virginia Beach - Stork Craft Recalls More than 500,000 Cribs - May 2009

IMAGE SOURCE: CPSC Web site/ image of trapped infant in drop-side crib

The head of the Consumer Product Safety Commission admits that the federal agency has not been acting as quickly as it should on defective cribs.

This follows the recall of more than 2.1 million Stork Craft Manufacturing Cribs following four infant suffocations and five million crib recalls over the past two years.

Interviewed on the morning new shows, Chairman Inez Tenenbaum pledged the CPSC would do better and act "firmly but fairly" to enforce the new law giving regulators more authority to police manufacturers.

Tenenbaum says she has just been on the job a few months and this case recently came in front of her.

But for years�drop-side cribs have been a focus of critical consumer advocates.�The drop-side design�allow one side to detach from the crib and slide down to more easily remove the baby. Besides suffocations, there have been 110 incidents of the drop-side actually detaching from the crib.

Asked if parents should abandon the ones they presently have, Tenenbaum�said yes. Consumers can also order plastic kits from the crib maker to immobilize crib sides.

Tenenbaum said she doubted there was a future for drop-side cribs. "The commission will write regulation in the next few months and we will look at this issue about drop-sides she said.

"But I don't think drop-sides will be part of cribs in the future."

The organization that set voluntary safety standards for the crib industry, approved a new standard just last week that required four fixed sides for full-side cribs, meaning that four-side cribs will no longer be manufactured.

Why are these ever made in the first place?

Nancy Cowles, of Kids in Danger, tells AP the agency must include more rigorous testing for cribs and their durability. "Parents should be able to trust that their child is safe in their crib," said Cowles.

The Resale Market

The problem is in the resale market.�Thousands of cribs sold in�garage sales, second-hand stores, and hand-me down cribs�are never recalled and are being used every day.

With more than 5 million crib recalls in recent years, you should know if yours is on the list.

November 2009 - 2.1 million cribs by Stork Craft Manufacturing of Canada recalled including 1.2 in the U.S. and 1 million in Canada. Cribs were sold back in 1993. Nearly 150,000 carry the Fisher-Price logo. Besides suffocation, Stork Craft have had problems with hardware that breaks or is missing and some are assembled incorrectly by owners which can cause the mattress to become wedged in an open space as well as the child. Cribs were sold in Sears, Wal-Mart, BJ's Wholesale Club, Target online, and Costco. Made in Canada, China and Indonesia.

January 2009 - Stork Craft - 500,000 cribs were recalled because of problems with metal brackets that support the mattress. Also the Stork Craft brand and some of the same models were part of Monday's announcement.

August 2008 - Simplicity Bassinet recall due to strangulation hazard. Six retailers agreed to stop the sale of the baby sleeping bed. Nearly 900,000 of the convertible close-sleeper/bedside sleeper bassinets were included. The recall followed the strangulation august 21, 2008 of a six month old girl from Shawnee , Kansas.

October 2007 - Simplicity full-size crib recall of more than one million, the largest recall in history at the time. The cribs were made by Simplicity between 1998 and 2007 and carry the Simplicity-made Graco brand name. A design flaw has resulted in the deaths of three children who became entrapped when a drop-rail was installed upside down, separated from the crib and leaving a gap the child can fall into and suffocate. The CPSC reports that the design flaw has also entrapped seven children and resulted in more than 50 "incidents" reported to the CPSC.

When the government announced the largest ever recall of full sized cribs in September 2007, parents had no idea that complaints had been coming in about the Simplicity-made cribs for years.

It was only on the eve of a Chicago Tribune investigation linking Simplicity (and Simplicity made Graco) cribs to the deaths of three children, seven trapped children and at least 55 complaints-that one million of the full-size cribs were "voluntarily" recalled by the Consumer Product Safety Commission (CPSC).

The CPSC and the Notorious 6 (b)

In the early 1970's the Consumer Product Safety Commission was given the authority to impose mandatory safety standards, a recall and ultimately a ban on unsafe products. But that was the non-controversial nature of consumer protection more than 30 years ago.

All of that changed around the time Ronald Reagan became president in 1980. The climate was "get government off our backs." At Reagan's Office of Management and Budget, David Stockman, wanted to entirely abolish the CPSC.

In 1981, the CPSC was amended. It would no longer be able to promulgate a "mandatory" safety standard.

Today manufacturers of 15,000 products -everything from lawnmowers to tires and baby cribs have the option to conduct a "voluntary recall" of faulty products. That means that the agency can avoid costly and time consuming litigation.

CPSC's Scott Wolfson, told IB News last year that the voluntary recall system has allowed the commission to conduct 472 recalls in 2007 alone. "That allows us to carry out more recalls in a given year than if we had to compel," he says.

Then there's, what Public Citizen calls the "notorious" 6(b) statute which governs how the commission disseminates product safety information to the public.

Former Commissioner Anne Graham says, "You know there is a problem, but you (as a commissioner) can't tell anybody about it until you go through the staff and you contact the industry. I'm not against trying to cooperate with industry but CPSC should not sit on something for a year when they are almost 99% sure there is a problem."

And section 6 (b) of the CPSC gives manufacturers the right to withhold information for thirty days or longer. The manufacturer has the right to approve whether or not information is released and can bring lawsuits against the CPSC to prevent disclosure of any information enclosed in a product notice.

Revised in 2008, the Consumer Product Safety Improvement Act of 2008 amends section 6 (b), shortening the time periods for notice from 30 to 15 days and shortened the time from 10 to five days that the Commission had to notify a company of its intent to disclose information over a problem. #

Originally posted at Jane Akre

CPSC Admits To Moving Too Slowly On Crib Safety

Chrissie Cole — Tue, 24 Nov 2009 11:03:00 GMT

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IMAGE SOURCE: © CPSC

In the wake of one of the largest crib recalls in U.S. history, the Consumer Product Safety Commission “concedes to not acting as quickly as it should regarding crib safety problems.”

Inez Tenenbaum, chair of the CPSC, was interviewed on morning news shows today and pledged that the agency would “firmly but fairly” enforce a law passed by Congress last year giving regulators greater authority to oversee the industry.

Yesterday, Stork Craft Manufacturing announced a recall of more than 2.1 million drop-side cribs in the United States and Canada following reports of four infant suffocations. Additionally, there have been 110 reports of incidents in which drop-sides detached from the cribs.

The recalled brand of cribs has had problems with their hardware which can break, or with assembly mistakes by the crib owner. These problems can cause the drop-side to detach, which can create a gap and entrap a child. Complete detachment of drop-sides can lead to falls from the crib.

In January, the company recalled about 500,000 cribs because of problems with metal brackets that support the mattress. The new recall includes some of the same models from the earlier recall, CPSC said.

Tenebaum was asked why federal regulators hadn’t stepped in sooner.

"We have not been acting as swiftly as we should have at the Consumer Product Safety Commission on these types of incidents," she replied. "I have just been appointed a few months ago to chair the CPSC and this case came in front of me just a few weeks ago."

In the past two years alone, more than 5 million baby cribs have been recalled – the recalls have been associated with the deaths of at least twelve young children.

CPSC is considering new rules for making cribs safer and could adopt recently approved standards set by ASTM International that requires immoveable, or fixed, sides for full-size cribs – which will eliminate the manufacture of drop-side cribs.

“Parents should be able to trust their child is safe in their crib,” said Nancy Cowles, of Kids in Danger. “The agency must include more stringent testing for crib durability.”

Mike Bryant, St. Cloud Injury Board Partner, says if you or a family member is injured by a product, immediate medical care is advised. If there is a significant affect or injury, you should contact an attorney concerning the problem as there may be time limits. Early investigation can include the collection of product, checking recall alerts, and the proper notifying of those who caused the problem.

For more information on the recall, visit the Stork Craft Web site or call the company toll free at (877) 274-0277. #

Originally posted at Chrissie Cole

CPSC - 2.1 Million Cribs Recalled By Stork Craft

Chrissie Cole — Mon, 23 Nov 2009 20:00:57 GMT

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IMAGE SOURCE: © CPSC

In one of the biggest crib recalls in U.S. history, Stork Craft Manufacturing announced a voluntary recall of more than 2.1 million drop-side cribs today.

According to the U.S. Consumer Product Safety Commission (CPSC), the recall involves 1.2 million cribs in the United States and approximately 1 million in Canada, where Stork Craft is based.

About 150,000 of the recalled cribs carry the Fisher-Price logo.

CPSC is aware of four deaths of young children who suffocated in the cribs, which have a side that moves up and down to allow parents to lift children from the cribs.

The cribs have had problems with their hardware, which can break, or with assembly mistakes by the crib owner.

The cribs were sold at major retailers in the United States and Canada including Kmart, JC Penney, Sears and Wal-Mart. They were also sold online at Amazon.com, Target.com and BabiesRUs.com and others.

Consumers should contact Stork Craft for a free repair kit that will convert the drop-side on the crib to a fixed side. The agency urges parents and caregivers to immediately stop using the recalled cribs. Parents should “find an alternative, safe sleeping environment for their baby,” the CPSC said in an e-mailed statement.

Consumers should not attempt to fix the crib without the proper repair kit.

Important CPSC Reminder:

Parents should not use any crib with broken, missing or loose parts.

Hardware should be checked and tightened regularly to ensure the crib is sturdy. When using a drop-side crib, parents should make sure the drop-side or other moving part operates properly.

Always check all sides and corners of the crib for disengagement, which can create a gap and entrap a child.

In addition, never attempt to repair a crib, using rope, tape or wire.

For more information on the recall, visit the Stork Craft Web site or call the company toll free at (877) 274-0277. #

Originally posted at Chrissie Cole

Flying With The Flu - 51 Percent Americans Say They Would

Jane Akre — Mon, 23 Nov 2009 13:23:00 GMT

Flying Sick�

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CDC- on Traveling Information
Airline Biz Blog- Dallas Morning News

�

IMAGE SOURCE: Wikimedia Commons/ Copenhagen Airport/ author: Jnpet

Thanksgiving is one of the busiest travel times of the year and no place seems as worrisome as the small contained area of an airline cabin, where hundreds of fellow travelers share the same space and breathe the same air, some of which contains airborne viruses.

"When people come together, germs can come together too," said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

Would you fly if you were sick?

Maybe you wouldn't but 51 percent of Americans say they would fly with the flu rather than pay for a flight not taken or a heavy penalty, according to a poll by TripAdvisor.com.

Families face huge penalties, like the one featured in the Airline Biz blog of the Dallas Morning News.

Their six-year-old became sick with the flu days before a family vacation on American Airlines. A cancellation fee of $150 per ticket would be imposed, even though the father argued for a medical waiver. That's the price of lower far tickets, says the airline.

"They are almost forcing people to fly when they have the swine flu, therefore subjecting others to the flu," reports CNN quoting the father.

USAir's policy also charges change fees to nonrefundable tickets.

Delta says it will work with the family with someone who is ill providing they have a doctor's note. The family can be rescheduled without a fee.

Dr. Stephanie Haridopolos, a family practitioner in Melbourne, Florida believes airlines should temporarily waive cancellation fees for H1N1-infected passengers who have a doctor's note.

"The current policies force people to choose their pocketbook versus their health," she said to CNN.

Travel Advisory

The Centers for Disease Control and Prevention recommends if you have a fever and a cough to avoid traveling until 24 hours after a fever has broken. While traveling, make sure you wash your hands often, and cover coughs and sneezes.

Due to the swine flu outbreak internationally, airport staff in some countries, including Japan and China, may check the health of arriving passengers.

You may be asked to pass through a scanner that checks your temperature or have your temperature taken with an oral or ear thermometer. Even quarantine is possible if you are sick, and the U.S. Department of State says it has no authority over what another country does.

The CDC reports that during the week of November 8-14, influenza decreased across all key indicators but overall remains high for this time of year. #

Originally posted at Jane Akre

Bristol-Myers Abilify Antipsychotic Approved For Autism Irritability

Jane Akre — Mon, 23 Nov 2009 11:58:17 GMT

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JAMA - Cardiometabolic Risk of Second-Generation Antipsychotics - October 2009
IB Help Center - Abilify
IB Help Center - Zyprexa
IB Help Center - Antipsychotics
IB Help Center - Children & antipsychotics�
IB News - Antipsychotic Prescriptions for Children Drop - May 2009
InjuryBoard News - What to do with a risky drug? Give it to children - December 2007
Injuryboard News - Harvard Psychiatrist on the hot seat for Conflict of Interest, November 2008
FDA - Atypical antipsychotics

IMAGE SOURCE: � Wikimedia Commons / Abilify/ author: Boboque�

Abilify for Autism

Bristol-Myers Squibb Co. (BMS) got some good news this weekend when the Food and Drug Administration (FDA) approved its top-selling Abilify to treat children for autism-related irritability.

BMS and Otsuka Pharmaceutical Co. of Tokyo are collaborators in both the development and distribution of Abilify in the U.S. and Europe, reports Business Week.

Abilify is given to children, ages six through 17 to treat aggression toward others, self-injury, moodiness and temper tantrums associated with autism. The companies say the drug should be used as part of a comprehensive treatment plan including psychological counseling, education and socialization.

An article in the December 2009 Journal of the American Academy of Child and Adolescent Psychiatry says any medication should be accompanied by a structured training program for parents to reduce serious behavioral problems in autistic children.

Abilify is a blockbuster for BMS. As its second largest revenue generator, it produced $2.2 billion in sales in 2008.

Abilify now joins a crowded field of medications for brain disorders.

ScheringPlough Corp.'s Saphris treats schizophrenia and bipolar disorder. Pfizer's Geodon, J & J's Risperdal, Astra Zeneca's Seroquel and Eli Lilly's Zyprexa have combined sales of over $15 billion a year.

A study published in the October 28 Journal of the American Medical Association, finds that so called-second generation antipsychotic medications have not been sufficiently studied in pediatric and adolescent patients and that first-time users experience an increase in bad cholesterol levels and a weight gain that is alarming.

Included were Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), or Abilify (aripiprazole). After 11 weeks, the patients had gained anywhere from 10 to 19 pounds on average. Zyprexa takers gained the most on average and Abilify users the least.

Additionally the Zyprexa patients showed higher LDL cholesterol and triglyceride levels, indicating more fat in the blood. Seroquel patients had higher triglycerides.

The degree of weight gain is alarming," said Dr. Wayne K. Goodman, head of a Food and Drug Administration advisory panel on the drugs last summer and chairman of psychiatry at Mount Sinai School of Medicine in Manhattan. "The magnitude is stunning," he said to the New York Times.

The young patients seem to lose the weight when they come off the drugs. The theory is that the drugs may block the signal of satiety.

Last year Canadian researchers found that elderly patients who are given antipsychotic drugs are three times as likely to experience serious health problems or death within a month of use, compared to those patients not given the drugs. #

Originally posted at Jane Akre

Senators Vote To Tackle Health Care Bill

Jane Akre — Mon, 23 Nov 2009 10:45:23 GMT

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Sen. Harry Reid- (D-NV) Web site
Full Text of Health Care Reform bill
CNN - What You Need to Know About Health Care Reform

IMAGE SOURCE: Washington Post Web site/ Sens. Durbin and Lieberman

Divisions Divide Senate

The big story this weekend- the U.S. Senate votes to open debate on a health care reform bill.

With no Republican votes, the 60-to-39 vote is the next step to passing a bill in the Senate which should begin after the Thanksgiving break.

Expanding health care to some 31 million Americans at no net cost to the federal government, the measure has some huge hurdles to clear such as access to abortion services, containing costs, and the largest and most controversial - a public option.

Unless a public option, a government-sponsored option to help the uninsured obtain health insurance, is left in, some Democratic Senators have said they will not cast their approval.

If Democrats can get 60 votes they can avoid a filibuster in the Senate, but even agreement on whether to debate the bill, just squeaked by.

One of the last to vote was Sen. Mary Landrieu of Louisiana. She had been promised more than $100 million to help her state, still crippled from Hurricane Katrina, pay for healthcare for the poor. She says more work on a health care bill needs to be done before she'll support it.

Sen. Bernard Sanders, an Independent of Vermont said in a statement, "While I voted to proceed to the health care legislation tonight, I have made it clear to the administration and Democratic leadership that my vote for the final bill is by no means guaranteed."

The other Independent in the Senate, Sen. Joseph I. Lieberman (Conn.), reiterated Sunday that he will oppose any bill that contains a public option. Appearing on NBC's "Meet the Press," he called such a government-run plan "radical."

Sen. Majority Leader Sen. Harry Reid (D-NV) said he knows not all Senators in the Democratic caucus agree on every aspect of the bill.

"The road ahead will be the toughest stretch. But we have momentum and I will keep this process moving forward," he said after the vote.

Speaking on the "Today" show, Sen. Charles Schumer says majority Democrats will push through a bill overhauling the health care system with or without Republican support, reports AP.

Sen. Richard Durbin of Illinois has suggested lawmakers may have to cut short their holiday recess.

The New York Democrat accused GOP lawmakers of seeking to kill it and said "they haven't put any alternative on the floor."

President Obama has promised healthcare reform as a major component of his presidency and wants to have the issue wrapped up before the end of the year.

To accomplish that, the Senate will have to work on its version, then differences will have to be worked out with the House version of reform. #

Originally posted at Jane Akre

The Senates' 60 Vote Showdown On Saturday

Jane Akre — Fri, 20 Nov 2009 22:19:02 GMT

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Sen. Harry Reid (D-NV) Web site
Text of H.R. 3590

IMAGE SOURCE: Sen Harry Reid video from Web site

Will They Pull Together?

Prior to a rare Senate Saturday session, Democratic leaders are ensuring they have critical last-minute commitments, the 60 votes needed before they can even begin debating health care reform in the Senate.

The Baltimore Sun reports that Nebraska Sen. Ben Nelson, who was a Democratic holdout, announced he would support a procedural vote Saturday. Blanche Lincoln of Arkansas and Mary Landrieu of Louisiana also expressed support of the motion to proceed.

If the 60 votes are cast Saturday, lawmakers would come back from their Thanksgiving recess November 30 and begin considering the proposed amendments from both sides of the aisle in the Senate.

Ultimately the house version of health care reform would have to be reconciled with the Senate version.

Senate Majority Leader Harry Reid (D-Nev.) unveiled the wide-ranging 2,074 page bill this week. The $848 billion measure would expand health insurance coverage to include another 31 million Americans over the next 10 years, and set up new online insurance purchasing exchanges and provide subsidies to those who cannot afford insurance.

Almost immediately, Republicans in the Senate showed their displeasure as did the business community.

“We’re disappointed.” That is the word from Bruce Josten, an executive VP of the U.S. Chamber of Commerce, about the health care reform plan introduced by Sen. Reid.

Some Republican lawmakers have vowed to filibuster the legislative process. All 58 Democratic senators and two independents must vote together to advance to the next stage of debate. The vote is set to take place at 8 p.m.

Reid reportedly promised Mary Landrieu a boost in aid for her state’s Medicaid insurance program for the poor for her support. He reportedly promised Oregon Sen. Ron Wyden to allow about one million to access new insurance exchanges.

He also agreed to slash proposed new taxes on medical device makers to appease Democrats such as Sen. Evan Bayh from Indiana that is home to manufacturers.

Those who oppose the public option provision, such as Sen. Joe Lieberman (I-Conn) said they may back a so-called ‘trigger” that creates a government plan in parts of the country when for-profit insurers could not provide quality insurance that is affordable.

Reid has a lot riding on the reform package as he is up for a six-year Senate term in 2010 and defeat could erode support for Mr. Obama and the Democrats in general

Mammograms And The Senate

This week Republicans seized on the policy to reduce mammograms and pap smears as an example of government rationed medical care to erode support of President Obama’s proposed health care overhaul.

This week a government panel that recommends the nation’s health care policies suggested women need not start mammograms regularly until their 40s.

The mammogram recommendations do not determine what services are covered under health care reform.

“This is how rationing starts,” said Jon Kyl of Arizona at a news conference.

"We're not rationing anything," said Rep. Lynn Woolsey, D-Calif. "It's a decision between a woman and her doctors."

The specter of the government making deeply personal medical decisions for millions of Americans — in this case, women — has been propelled in part by the Republican drive to stymie the Democratic bill reports AP.

As it stands now all states except Utah force insurers to cover mammograms. #

Originally posted at Jane Akre

Thermal Imaging May Top Mammograms

Jane Akre — Fri, 20 Nov 2009 00:47:57 GMT

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International Academy of Clinical Thermology –find a practitioner
Dr. Susan Lark -Web site
US Preventive Services Task Force –Breast Screening Recommendations, November 2009

IMAGE SOURCE: IMAGE SOURCE: Dr. Lark Web site, Healthy Directions LLC

What is a woman to do with the information this week discouraging annual mammograms?

It was almost as shocking as the 180-degree turnabout when doctors went from encouraging hormone replacement therapy to almost overnight in 2002, deciding HRT was linked to an increased risk of heart attack and stroke.

The U.S Preventive Services Task Force, which sets recommendations for the nation, essentially said that women between the ages of 40 to 49 should not get annual mammograms unless they are high-risk such as a family history because the risks of screening outweigh the benefits.

Mammograms should be reserved for women over the age of 50, but every two years instead of annually. Most perplexing was the recommendation that women should no longer be encouraged to do self-breast exams.

Dr. Susan Lark, an anti-aging, preventive medicine, and women’s health specialist with a strong online presence, says she is angered by the new guidelines that discourage self-exam and agrees with other recommendations.

She has been writing about a better alternative to mammograms for decades because of the risks.

In her February 2008 issue of her newsletter, Women’s Wellness Today she writes,
"A routine mammogram's sensitivity (how good it is at detecting suspicious tissue) varies. If a woman is still menstruating, her breast tissue is denser, which drops the sensitivity of routine mammograms to below 70 percent. That means that as many as 30 percent of existing breast cancers are missed, which is troubling because cancers in younger women tend to grow faster.”

The other problems with mammograms:

Smaller rumors are less likely to show up if they are about four-tenths of an inch
Human error missing tumors in reading mammograms is always possible, giving them time to grow

Dr. Lark instead encourages women 40 and over a breast imaging test called thermography. Like a person’s fingerprint, the image is uniquely yours and doesn’t change much over time.

Here’s how it works. When an adult stops growing, her breasts register cool on the thermogram.

Tumors, however, exert energy as they grow and requires blood supply and usually generates extra heat, enough to show up on a thermogram. The heat reading will show up long before it would on a mammogram. Over time as the tumor grows, they get hotter.

Noncancerous structures such as cysts and abscesses on the other hand cool down, something the thermogram can see. An added benefit – thermography does not involve radiation so you can return to be reevaluated.

Dr. Lark recommends getting a baseline thermogram that compares the left and right breasts so the two sides can be compared for suspicious tissue. Repeating the procedure every couple of years provides a baseline for comparison images taken in the future.

“A spot on one breast but not the other might be a normal part of your "fingerprint" that's been there for years, or it might be entirely new-and clinically significant,” says Dr. Lark.

“In short, mammography looks at the structure of a woman's breast tissue, while thermography looks at its behavior,” she says.

Dr. Lark encourages high risk women to get mammography and thermography, as well as keep up with breast self-exams, because you are best able to know about the health of your breasts. #

Originally posted at Jane Akre

Vicks Nasal Spray Recalled By P&G

Chrissie Cole — Thu, 19 Nov 2009 19:14:47 GMT

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Vicks Press Release
IB News - Parents Warned Against Using Vicks VapoRub On Children, Jan. 2009
IB New York City – P&G Warned Over Vitamin C In Vicks Products, Oct. 2009

Proctor & Gamble is voluntarily recalling three lots of its Vicks Sinex nasal spray in the United States, the United Kingdom and Germany.

During a routine quality control inspection small amounts of bacteria B. cepacia was detected. The recall affects about 120,000 bottles.

While there have been no reports of illness associated with the recalled products, the bacteria could cause serious infections for an individual with a compromised immune system or a chronic lung condition such as cystic fibrosis, P&G said in a news release. However, the bacteria pose little medical risk to healthy individuals.

The recalled medication should not be used. Consumers should contact P&G for a full refund or replacement coupon.

The nasal sprays were sold in 15 milliliters bottles in all three markets and include the following lot numbers:

In the U.S.: 9239028831 - Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist

In the U.K.: 9224028832 - Vicks Sinex Micromist Aqueous Nasal Spray Solution

In Germany: 9224028833 - Wick Sinex Schnupfenspray Dosiersystem

* The lot number is listed on both the outer carton and the bottle.

Consumer Contact:

United States, call: 1.877.876.7881

United Kingdom, call: 0800.5555.15

Germany, please call: 0800.111.6131

According to a spokesman for P&G, 4.4 million bottles of the spray were sold in the U.S. alone in 2008.

The recall is just weeks after the Food and Drug Administration (FDA) warned P&G that its Vicks cold formulas with Vitamin C have false and misleading labeling. #

Originally posted at Chrissie Cole

Medtronic Gets FDA Warning After Inspection

Jane Akre — Wed, 18 Nov 2009 11:02:23 GMT

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Medtronic letter to physicians March 13, 2009
IB Help Center- Sprint Fidelis Leads
FDA on Medtronic
Medtronic Web site
IB News - Medtronic Heart Device: More Fatalities Revealed - April 2009
NEJM Editorial - on The Medical Device Safety Act of 2009, March 18, 2009

IMAGE SOURCE: Medtronic Web site/ Medtronic Sprint Fidelis lead

FDA Inspection Finds Problems

Medtronic, the maker of medical devices that corrects heart rhythms, has been ordered to fix problems at its Minnesota factory following a Food and Drug Administration (FDA) inspection at its manufacturing plant.

The company received a warning letter from health regulators to take immediate action, though the company didn't detail the FDA's concerns uncovered during the August inspection at its Mounds View, Minnesota facility.

The heart implants division makes cardiac rhythm disease implants, including pacemakers and other surgically implanted medical devices that slow or stabilizes the heart beat, reports AP.

The�Wall Street Journal reports that the problems fall into four general categories - corrective and preventive action and field-action timeliness; review and documentation of field-action recommendation; supplier qualification; and control and medical-device reporting timeliness.

So far this year, Medtronic has issued two recalls - one a wiring defect in pacemakers in May. In July it recalled some defibrillators that were malfunctioning in the�presence of humidity.�

These were noted to be Class I recalls, a FDA designation that is the most serious putting patients at risk of injury or death.

In April, Medtronic's Sprint Fidelis cardiac wire was implicated in more than the five deaths the company previously revealed after an independent panel of physicians said the count is closer to 13.

The wire, attached to a defibrillator, was in the heart of some 270,000 patients when Medtronic stopped making the defective product in October, 2007. At that time the company estimated five people might have died as a result of its malfunction.

There are about 2,200 reports of serious injuries from the lead, reported to the Food and Drug Administration.

The company released information about the increased number of deaths after a federal judge earlier this year dismissed more than 700 consolidated cases charging product liability, negligence, fraud, and breach of contract, among others against Medtronic, filed in U.S. District Court in Minnesota.

Judge Richard Kyle, cited last year's Riegel decision in dismissing the lawsuits. In Riegel, the U.S. Supreme Court ruled in favor of medical device makers affirming they enjoy a shield since their products have FDA approval.

The company has 15 days to respond to the latest problems and says it has already started to implement changes.

Medtronic stock was recently down 15 cents at $40.05 in premarket trading, though is up 28 percent so far this year. #

Originally posted at Jane Akre