FDA has determined that the Stryker cranial implant recall is a Class I recall, which means the product could pose an imminent hazard to health. After determining that the sterilization validation of the product was not performed according to appropriate standards, Stryker CMF recalled 322 Custom Cranial Implant Kits.

Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.

Custom cranial implant is designed individually for each patient to correct trauma and/or defects in the lower jaw (mandibular), upper jaw and face (maxillofacial) or the cranium and the face (craniofacial bone).

Our law firm handles wrongful death and injury claims involving post-operative infections, including Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli (E. coli). In these cases, there may be both product liability and medical malpractice claims.

To contact a lawyer about an infection after implant surgery, please call 1-888-377-8900 (toll-free) or submit our case review form.

Keywords: Stryker cranial implant recall, jaw implant infection, face implant infection, implant surgery, wrongful death, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli.

Posted December 2008

Labels: e coli, escherichia coli, pseudomonas aeruginosa, staphylococcus aureus

We are representing a number of people who developed kidney failure after using Fleet Phospho-Soda for bowel cleansing before a colonoscopy. Fleet Phospho-Soda is an over-the-counter oral sodium phosphate product.

Due to the great number of people who have experienced kidney failure (renal failure) after using this product, the FDA has decided to amend its position on Fleet Phospho-Soda and other over-the-counter sodium phosphate products. As a result, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System.

For more information about the Fleet Phospho-Soda recall, please see the following:

• Fleet Lawsuit for Acute Phosphate Nephropathy
  
• Fleet Recall

To contact an attorney at our law firm form information about our Fleet Phospho-Soda lawsuits, please call 1-888-377-8900 (toll-free) or submit our free Fleet consultation form.

Labels: Fleet Lawsuit, Fleet Phospho-Soda, Kidney Failure

The FDA has announced an Herbal Science International recall of dietary herbal supplements. Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) has recalled twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers, according to the FDA.

The company is recalling nine products that contain ephedra, a source of ephedrine alkaloids, as an ingredient sold labeled under the following brands:

Wu Yao Shun Qi San
Qing Bi Tang (Nasal Cleanser)
Zhong Fong Huo Luo Wan (Stroke Revito Formula)
Xiao Qing Long Tang (Little Green Dragon)
Ding Chuan Tang
Xiao Xu Ming Tang
Feng Shi Zhi Tong Wan (Joint Relief)
Guo Min Bi Yan Wan
Fang Feng Tong Sheng San

Herbal Science International, Inc. is also recalling Tou Tong San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo Joint Relief), two products containing aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. These products have also been linked to an increased risk of kidney cancer in people who have consumed them.

Finally, the company is recalling Seng Jong Tzu Tong Tan, a product that contains human placenta. Human placenta may transmit disease and dietary supplements that contain it may not be lawfully marketed in the United States.

All of the twelve products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.

The FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.

Read the full Herbal Science international recall announcement on the FDA website.

Posted April 2008.

Labels: dietary supplement recall, ephedra, ephedrine alkaloids, Herbal Science International

On March 27, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of serious, adverse reactions from persons in nine states, Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Posted April 2008.

Labels: FDA recall, selenium, Total Body Formula

We are not taking heparin cases.

Labels: baxter heparin recall, Heparin, product liability

Actavis Inc. has announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This Fentanyl patch recall is an expansion of an initial Fentanyl recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008 (Fentanyl recall - Fentanyl death - Fentanyl overdose). That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the Fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

Fentanyl patches are dangerous, and anyone coming in contact with the Fentanyl gel within the patch is at risk for serious adverse events, including respiratory depression and possible overdose, which may cause death.

If you are using a Fentanyl patch and have not experienced any adverse events, you need to contact your medical provider immediately.

If you believe you have been injured by Fentanyl, contact one of our lawyers regarding this Fentanyl patch recall and other Fentanyl recalls. You may be entitled to compensation for your injuries. If a family member died after using a Fentanyl patch, contact us for information on wrongful death litigation. To contact us, please call toll-free at 1-888-377-8900 or submit our free case consultation form.

Again, this Fentanyl patch recall is extremely serious and all caution should be used regarding the Fentanyl patches. We urge you to contact your medical provider immediately if you are using a Fentanyl patch. We also urge you to send this information to anyone you know who may be using a Fentanyl patch.

Posted March 2008.

Labels: Fentanyl Patch Recall, Free Consultation, Lawyers

B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes. (Read about the AM2Pat Inc. Heparin Recall.) This recall has prompted B. Braun Medical to recall its affected products, which includes the following Heparin syringes and normal saline flush syringes:

• Normal Saline 3mL in 12 mL Syringe, Catalog #513584
• Normal Saline 5mL in 12 mL Syringe, Catalog #513586
• Normal Saline 10mL in 12 mL Syringe, Catalog #513587
• 10 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513610
• 100 units/mL Heparin, 3mL in 12 mL Syringe, Catalog #513611
• 100 units/mL Heparin, 5mL in 12 mL Syringe, Catalog #513612
  

Customers that have the recalled product in their possession should discontinue use immediately. Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

We are investigating cases involving Heparin products. To contact a lawyer at Pritzker | Ruohonen, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Labels: B. Braun Heparin Syringe Recall, B. Braun Recall, Serratia marcescens