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Five More Lawsuits Over Contaminated Pre-Fill Syringe

Posted by Jane Akre
Monday, January 28, 2008 9:56 AM EST
Category: Major Medical, Protecting Your Family
Tags: Heparin, Defective Products, Drug Products, FDA and Prescription Drugs, Medical Devices, Toxic Sutstances, Defective and Dangerous Products

5 more lawsuits filed over bacteria contamined pre-filled syringes.

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Five more lawsuits have been filed over bacteria-tainted syringes. 

Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines. 

In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago.

14 of those patients required hospitalization from five to nine days.   All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria, Serratia marcescens.  

All five plaintiffs are Illinois residents.

They join a 30-year old leukemia patient, Katie Abrams, who filed the first lawsuit concerning the tainted syringes. In her suit she claims the bacterial contamination made her violently ill with 105 degree fever and she was hospitalized for nine days. 

On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.  Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens.

The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.                

Look for brand names Sierra Pre-Filled Inc. and B. Braun in both 3 ml and 5 ml sizes and also 10 ml for Normal Saline.   Any consumer or facility that has these products on their shelves should discontinue using them, quarantine them and return them to the distributor.  The syringes were sent to Florida, Texas, Illinois, Colorado and Pennsylvania. 

The North Carolina company was found not to be in compliance with FDA regulations for quality control and sterilization procedures.

Consumers with questions may contact the company at 1-919-552-9689 or 847-691-6500 { MONDAY THROUGH FRIDAY 9AM EASTERN TILL 5PM EASTERN}

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.  #

 


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