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Car Accidents
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Posts Tagged ‘recall’

Recall Warning: Lifescan OneTouch SureStep Test Strips Yield False Results

defective product attorneys, defective products, recall

March 1st, 2010: Law Blogger

Defective Product LawyersThe technology for testing blood glucose (sugar) levels which aid in helping diabetics control their insulin levels has made major strides in the last decade. The painful thumbtack has been replaced by high tech digital reading devices. Though far more sanitary, pleasant, and convenient, technology has its flaws. When gauging the insulin levels, a mechanical error can have disastrous results.

Now Lifescan has issued a voluntary recall of 8 items in their product line. Lifescan is a subsidiary of medical equipment and pharmaceutical giant Johnson & Johnson.

On their website, Johnson & Johnson confirmed the recall and elaborated that the Lifescan Onetouch meter that these strips go to was discontinued both in Canada and the US in 2006, but the company remained providing strips for them. They added that their new Onetouch is vastly different technology and superior, suggesting that it is time for an upgrade.

Lifescan OneTouch SureStep Recall Details

The Food and Drug Administration (FDA) has issued an open letter to the public and health care providers such as nursing homes, hospitals, clinics, and other facilities regarding using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems. These glucose measuring systems use SureStep®Pro® Test Strips.

The full list of recalled products include:

  • 100-ct – OneTouch SureStep  # 2969251
  • 100-ct – OneTouch SureStep  # 2969798
  • 100-ct – OneTouch SureStep  # 2982369
  • 100-ct – OneTouch SureStep  # 2983467
  • 50-ct – OneTouch SureStep  # 2969795
  • 50-ct – OneTouch SureStep  # 2982566
  • 50-ct – Medicare/Mail Order # 2969481
  • 50-ct – Medicare/Mail Order # 2998193

These products may produce false low readings when the blood glucose reading is greater than 400 mg/dL. The FDA and LifeScan has advised healthcare facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips.

It has been advised that healthcare facilities with access to alternative means of testing should consider discontinue using SureStep Systems until non-defective replacement test strips are available.

Consumers are advised to use alternative methods if available. If none are available, continue using the strips and contact a physician if levels are greater than 400 mg/dL.

Lifescan OneTouch SureStep False Readings Side Effects

Defective Medical DevicesRecently in February, 2010 a diabetic professor at a college in Washington state was standing in the hall of his college and he had no idea where he was. He had gone into diabetic shock. He approached a colleague as if they were a stranger and ask the way outside. She realized by his glossed over look that there was something seriously wrong.

In the hour that followed medical crews arrived and proceeded to physically fight with the professor as his worst nightmares rushed to his head, not being able to recognize that they were trying to help him. They got him sedated and to the hospital just in time. He very well could have slipped into a coma. This is an extreme case, but extreme cases are what happens when a diabetic’s warning system isn’t working effectively.

The side effects that tell a diabetic that they have not properly regulated their glucose and insulin levels can be very subtle. As you might realize from the story about the professor above, the side effects can sneak up and have dire results. Watch for some of these side effects when using the Lifescan Ontouch Surestep product line:

  • shaking
  • sweating
  • irritability
  • headache
  • tingling
  • hunger
  • blurred vision
  • dizziness and confusion
  • numbness of the lips
  • nausea or vomiting
  • fast heart rate
  • sudden tiredness
  • seizures
  • pale appearance
  • frequent sighing
  • personality change
  • confusion or poor concentration
  • loss of consciousness

Protect Yourself from Harm from Recalled Products

This is a voluntary recall by Lifescan because of reports from healthcare providers and consumers. Though Johnson & Johnson has stopped producing these machines does not mean that they are not liable for their correct operation, particularly in life threatening situations such as the most dangerous of side effects of misread insulin levels in diabetics.

If you or a loved one have found yourself a victim of this recall or other defective medical devices it is important that you get representation that has proven experience with defective product litigation when dealing with large companies that have endless resources. Call Phillips Webster to review your legal rights and find out your legal options.

The Dangers of Anosmia – Why the Zicam Issue Matters

anosmia, defective drugs attorneys, depression, FDA, gas leaks, injuries, loss of sense of smell, recall, side effects, Zicam

June 18th, 2009: Washington Law Blogger

When people hear about products being recalled and the FDA warning the public to stop using them because of a link to serious side effects, most would assume those side effects are more severe than the loss of the sense of smell. Anosmia, as it’s known in medical circles, is a condition that’s been diagnosed more than 130 times in consumers who had used certain Zicam products, and as a result it’s no longer available in retail outlets around the country.

We’ve been posting about the details of the issues involving Zicam lately, but some are wondering why anosmia is something to be concerned with, when other products have been known to cause cancer and death. However, basic research will tell anyone that the loss of the sense of smell, particularly if it’s permanent, can be a dangerous condition for several reasons.

When someone cannot smell, the most obvious danger it creates is that those people may not be able to sense dangers that include smoke from a fire or poisonous substances or gas leaks. However, there are other problems associated with anosmia, and they are directly correlated with the longer duration of this condition.

Those who cannot smell will often fall into a depression, as they understand that they are physically limited and are also concerned about their lack of ability to detect the dangers described above. Medical experts have also noted that those with anosmia will slowly lose weight as a result of a loss of appetite, and this can create many other medical problems that are high-risk in nature.

Ultimately, anosmia is a serious enough side effect that the FDA ordered the makers of Zicam to stop marketing the product and for Matrixx Initiatives, Inc., the manufacturer, to voluntarily pull the products from the shelves. If you or someone you love has been injured as a result of using Zicam, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Zicam Removed from Retail Shelves

ansomia, attorneys, FDA, injuries, Matrixx Initiatives, recall, side effects, warning, Zicam

June 17th, 2009: Washington Law Blogger

Yesterday, we alerted our readers to the fact that the US Food and Drug Administration (FDA) had issued a public warning regarding the dangers associated with several Zicam products. The agency also delivered a letter to Matrixx Initiatives, Inc. stating that they had to stop marketing these products unless they decided to put them through the normal FDA approval process that’s required of other medications.

Today, Matrixx Initiatives, Inc. responded by voluntarily pulling the products in question from retail shelves across the United States until the matter is resolved. The three specific products within the overall product line that were pulled include:

  • Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
  • Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
  • Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

To reiterate the warning issued by the FDA yesterday, you should immediately stop using these products if you have them in your home.

The reason this issue arose is because the FDA received at least 130 reports of consumers using the Zicam products listed above and developing ansomia, which is the loss of the sense of smell. Consumers reported the development of this side effect soon after use, and while no duration of the condition has been defined, some reported that it took several months for their sense of smell to return.

It’s believed that zinc, one of the ingredients in Zicam products, was the reason for this side effect, as it has been known to create similar problems in people who have been exposed to it in the past. If you or someone you love has been harmed as a result of using Zicam, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

Hydroxycut Products Recalled

attorney, Defective Drugs, defective products, dietary supplements, FDA, Hydroxycut, recall, side effects

May 6th, 2009: Washington Law Blogger

The makers of Hydroxycut announced a recall of 14 products, effective immediately on the heels of scrutiny from the US Food and Drug Administration (FDA). The specific products recalled were:

  • Hydroxycut Regular Rapid Release Caplets
  • Hydroxycut Caffeine-Free Rapid Release Caplets
  • Hydroxycut Hardcore Liquid Capsules
  • Hydroxycut Max Liquid Capsules
  • Hydroxycut Regular Drink Packets
  • Hydroxycut Caffeine-Free Drink Packets
  • Hydroxycut Hardcore Drink Packets (Ignition Stix)
  • Hydroxycut Max Drink Packets
  • Hydroxycut Liquid Shots
  • Hydroxycut Hardcore RTDs (Ready-to-Drink)
  • Hydroxycut Max Aqua Shed
  • Hydroxycut 24
  • Hydroxycut Carb Control
  • Hydroxycut Natural

The products were recalled because of at least 23 reports of serious side effects developing in consumers who purchased more than 9 million containers of it within the past year. The side effects involved serious damage to consumers’ kidneys and livers, and one 19-year-old man died after using Hydroxycut.

Hydroxycut was a popular product line because it marketed itself as a ‘natural weight loss’ solution that used natural products. However, it has yet to be determined which ingredient or ingredients are responsible for these side effects, as the ingredients seem to have changed several times.

If you have been using any of these products, you need to stop using them immediately, as was stated by the FDA. If you’ve been injured as a result of using them, you need to contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.