LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are:

Lot #’s are located on the outer carton and test strip vial.

Patients with test strips from the recalled lots are asked to call LifeScan at 800 574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit www.SureStep.com to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported. However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue. All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips. However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips. Today, OneTouch SureStep Meter users represent a very small portion of LifeScan’s total customer base. The vast majority of LifeScan’s customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit www.OneTouchDiabetes.com.

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955

Source: fda.gov

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Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Audience: Emergency medical professionals, hospital risk managers

[Posted 02/09/2010]: Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.

Full Press Release

Source: fda.gov

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Cardiovascular diseases are our nation’s number one killer. Since 1963 Congress has required the president to proclaim February “American Heart Month”. During this month the goal is to raise funds for research and pass along information about heart disease and stroke.

Not only does the American Heart Association work with administration to draft and sign this annual proclamation they also designed “My Life Check – Live Better With The Simple 7” with the goal of educating the public on how to improve their health one step at a time.

You probably guess most of these, if not all of them, but it’s never a bad idea to remind yourself of 7 Steps to a Healthier Life.

• Get Active
• Eat Better
• Lose Weight
• Stop Smoking
• Control Cholesterol
• Manage Blood Pressure
• Reduce Blood Sugar

Checkout My Life Check for more information on The Simple 7 and to get your own personal assessment test.

Sources: americanheart.org, mylifecheck.heart.org

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TORRANCE, CA – January 21, 2010 – Pelican Products, Inc., the global leader in the design and manufacture of advanced lighting systems and virtually indestructible cases, today announced its contribution of $100,000 worth of head lamps and flashlights to the Haiti relief effort. The in-kind donation will help aid and assist rescuers, volunteers and emergency response teams in their relief efforts in Haiti.  Emergency triage shelters are without lighting, so head lamps allow doctors to treat patients in completely dark locations.

“Our prayers go out to the people of Haiti,” said Lyndon Faulkner, Pelican’s President and CEO. “It is impossible to see the devastation and not want to help. We hope that our donation, along with the donations of others across the county, will help bring some relief to the people of Haiti.”

Pelican™ cases are also being utilized by emergency response teams to transport and carry supplies to Haiti. Pelican cases are some of the most durable, longest lasting protector cases and are engineered to be completely watertight, crushproof and dustproof.

Source: pelican.com

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The NYC ½ Marathon lottery closed last Wednesday night (1/6/10) and the winners were announced on Thursday. If you didn’t make it and you still want to take part in it you still have a chance. The FAF Team still has spots available. If you’re interested you can register with the Fresh Air Fund.

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Since 1970 the first month of the year has been recognized as National Blood Donor Month. Why not kick off the New Year with a blood donation to your local Red Cross or other blood bank in honor of National Blood Donor Month? The whole process takes only about an hour of your time.

If you’re at least 17 years old, weigh at least 110 pounds, not on antibiotics, without infection or fever, feeling healthy the day of and it’s been at least eight weeks since your last donation why not go for it? There are some other guidelines but those are the biggies.

Blood has a shelf life of only 42 days. That means it constantly needs to be replenished. In the midst of not only cold and flu season but the rise in car accidents during the winter season clean, backup blood is needed.

For information on where you can donate blood here’s a link to the American Association of Blood Banks (AABB) which has a handy Blood Bank Locator Map.

Sources: aabb.org, healthnews.com, redcross.org

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FDA PRESS RELEASE

For Immediate Release: Dec. 23, 2009

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
Accelerated approval process used in vaccine approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.

Fluzone High-Dose was approved via the accelerated approval pathway. FDA’s accelerated approval pathway helps safe and effective medical products for serious or life-threatening diseases become available sooner. In clinical studies, Fluzone High-Dose demonstrated an enhanced immune response compared with Fluzone in individuals 65 and older.

As part of the accelerated approval process, the manufacturer is required to conduct further studies to verify that the Fluzone High-Dose will decrease seasonal influenza disease after vaccination.

“As people grow older, their immune systems typically become weaker,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This is the first influenza vaccine that uses a higher dose to induce a stronger immune response that is intended to better protect the elderly against seasonal influenza.”

Fluzone High-Dose, manufactured by Sanofi Pasteur Inc., is formulated so that each 0.5 mL dose contains a total of 180 micrograms (mcg) of influenza virus hemagglutinin (HA) which is made up of 60 mcg of each of the three influenza virus strains.

Other currently licensed seasonal influenza vaccines for adults are formulated to contain a total of 45 mcg of influenza virus hemagglutinin (15 mcg HA from each of the three influenza strains per dose). Sanofi Pasteur, also manufactures Fluzone, a seasonal vaccine for the United States approved for use in individuals ages 6 months and older.

As expected, because of the higher HA content, non-serious adverse events were more frequent after vaccination with Fluzone High-Dose compared with Fluzone. Common adverse events experienced during clinical studies included pain, redness and swelling at the injection site and headache, muscle aches, fever and malaise. The rate of serious adverse events was comparable between Fluzone High-Dose and Fluzone.

People with hypersensitivity to egg proteins or life-threatening reactions after previous administration of any influenza vaccine should not be vaccinated with Fluzone High-Dose.

Fluzone High-Dose is administered as a single injection in the upper arm and is available in single dose pre-filled syringes without preservative.

Source: fda.gov

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Do you enjoy running? Do you live in the NYC area or will be there on March 21, 2010? If so, get your running shoes ready.

On March 21, the Fresh Air Fund-Racers will be taking it to the streets in the NYC Half-Marathon. There’s limited availability so if you’re interested register here on the double!

Every year The Fresh Air Fund gives thousands of inner-city children the priceless gift of fun and opens the door to a lifetime of opportunities. Whether a country trip with a host family or an educational stay at one of The Fresh Air Fund camps their programs are providing lifelong memories and friendships.

Source: FreshAirHoliday.org, nyrr.org

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December 1st is World AIDS Day. World AIDS Day was established by the World Health Organization in 1988. This day allows governments, national AIDS programs, faith organizations, community organizations, and individuals an opportunity to raise awareness and focus attention on the global AIDS epidemic.

According to the CDC at the end of 2006 an estimated 1.1 million people were living with diagnosed or undiagnosed HIV infection in the United States. Worldwide an estimated 33 million people are living with HIV.

It doesn’t have to be World AIDS Day to take action against HIV/AIDS but now is as good as any day to start. Here are some ideas on how you can take action today:

Sources: cdc.gov, hhs.gov

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