Legal Specialties > Dangerous Drugs > Heparin

Drug INFORMation

DRUG MANUFACTURER: 
AM2 PAT, Inc., of Angier, North Carolina

BRAND NAME: 
Sierra Pre-Filled, Inc.

PRODUCT DESCRIPTION:

Heparin Lock Flush Solution USP, all strengths and sizes

Normal Saline IV Flush Solution USP, all strengths and sizes

BRAND NAME: 
B. Braun Products

PRODUCT DESCRIPTION:

Heparin Lock Flush - 10 units/mL 5mL in 12 mL Syringe

Heparin Lock Flush – 100 units/mL 3mL in 12 mL Syringe

Heparin Lock Flush – 100 units/mL 5mL in 12 mL Syringe

Normal Saline IV Flush – 3mL in 12 mL Syringe

Normal Saline IV Flush – 5mL in 12 mL Syringe

Normal Saline IV Flush – 10 mL in 12 mL Syringe 

Heparin REcall News

Heparin Taint Tied to Deaths
The Chicago Tribune — July 30, 2008

FDA boosts number of heparin-related deaths
Reuters — June 16, 2008

FDA Probes Devices Containing Heparin
Wall Street Journal — June 6, 2008

Medtronic Recalls Select Heparin-Coated Devices and Products Used During Heart Surgeries
FDA Web site — May 7, 2008

Heparin Contamination May Have Been Deliberate, FDA Says
81 deaths linked to contaminated blood thinner
New York Times — April 30, 2008

FDA Warns Public of Contaminated Heparin IV Syringes
FDA Web site — January 25, 2008

 

 

 

Contaminated Heparin IV Syringes

On January 25, 2008, the U.S. Food and Drug Administration (FDA) announced a nationwide Class I recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, North Carolina. Two lots had been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. The FDA stated, “This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.”

Topics on this page:

• Bacterial Contamination Causes Infections
• Types of Infections
• Symptoms
• The FDA Identifies the Recalled Brands
• What to Do if You Have Used a Contaminated Heparin IV Syringe
• Contact an Attorney Experienced with Dangerous Drug Recall Cases

 

Bacterial Contamination Causes Infections

All Heparin Lock Flush syringes from Lot 070926H and Normal Saline Syringes from Lot 070917A, have been found to be contaminated with infection-causing Serratia marcescens bacteria.

The U.S. Centers for Disease Control and Prevention (CDC) has found this dangerous bacteria in unopened heparin syringes.

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Types of Infections

The Serratia marcescens bacteria has been linked to:

• Pneumonia
• Blood infections
• Urinary tract infections
• Wound infections

About 40 people have been infected in Illinois and Texas, but the product has been distributed in other states, including Colorado, Florida, and Pennsylvania. 

Twenty outpatients of the Rush University Medical Center in Chicago became infected, and most required hospitalization. They responded well to antibiotic treatment. No deaths have been reported to date.

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Symptoms

Infected patients have reported becoming violently ill, with symptoms including vomiting, high fever, and chills.

One 30-year-old leukemia patient reported being hospitalized for more than a week after developing an infection believed to be linked to the use of a contaminated Sierra Pre-Filled Syringe at home. 

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FDA Identifies the Recalled Brands

The contaminated syringes were manufactured by AMT PAT, Inc., of Angier, North Carolina. All of these syringes have the National Drug Code or NDC Prefix of “64054.”  They have been distributed to both inpatient and outpatient facilities as well as directly to patients for use at home.

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If You Have Used a Contaminated Heparin IV Syringe

If you are a patient who used the recalled contaminated heparin IV syringes, you should:

• If you have used Sierra Pre-Filled or B. Braun Heparin or Saline Flush Syringes, either at home or in the hospital, and if you have developed an unexplained systemic infection, you should consult your doctor immediately for a full medical evaluation.
  
  
• If you have any unused product on your shelves at home, secure it in a place where it cannot be used, and return it to the pharmacy or hospital where you obtained it.  BE SURE TO ASK FOR A RECEIPT, in case you should have to prove your exposure to the contaminated syringes in the future.
  
  
• Tell your doctor that you have been exposed to contaminated syringes that have been recalled by the FDA, even if you have not had symptoms of infection.

 

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Contact an experienced drug recall attorney

If you or a loved one has been injured because of exposure to contaminated Heparin IV syringes, you may be entitled to compensation for:

• Medical treatment
• Hospitalization
• Lost wages
• Pain and suffering
• Other damages arising from your exposure 

KCR personal injury attorneys have handled thousands of cases involving defective and dangerous drugs such as Heparin. In recent years, KCR has litigated and settled numerous nationwide cases involving dangerous drugs and medical devices and products such as:

• Vioxx
• Phen-Fen diet drugs
• Intergel anti-adhesion surgical product
• Guidant defibrillators and pacemakers

We have the specific knowledge and expertise to help our injured clients obtain fair compensation in these complex cases. Some of the recent cases we've resolved include:

• $240 Million Guidant Defibrillator Settlement — KCR clients who were injured by malfunctioning Guidant cardiac defibrillators will claim shares of the $240 million fund as part of a 2008 nationwide settlement.
  
  
• In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
  
  
• In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.

If you or a loved one has been exposed to the recalled contaminated Heparin and Saline Pre-Filled Flush Syringes, and if you have developed an unexplained systemic infection, you may be entitled to compensation for medical treatment and other damages arising from your exposure. Please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333.

 

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