Massachusetts Personal Injury Lawyer Blog

FDA Recall Of Serratia-Contaminated Syringes

In January 2008 the Food & Drug Administration (FDA) issued a nationwide recall on syringes manufactured by AM2 PAT for both the heparin and saline-filled syringes. 

The syringes were contaminated by bacteria called Serratia marcescens, which can cause serious injury or death. 

One of the more significant effects of the contaminated syringes can be the interruption of the treatment which required the use of the syringes. This, with the infection, could significantly affect the outcome of the treatment. If chemotherapy has to be stopped, even temporarily, because of the infection the treatment might not be as effective and also extends the length of time the patient has to undergo the chemotherapy.  

• If you still have syringes, DO NOT USE THEM.
• Contact the company that provided the syringes IMMEDIATELY.
• Tell your doctor that you have been exposed to Serratia so that you and your doctor can be aware if you develop symptoms that might indicate an infection.  

Serratia marcescens is usually found in water and soil has been linked to:

• Pneumonia;
• Blood infections;
• Urinary tract infections; and
• Wound infections. 

Some patients whose treatment required the use of the recalled syringes developed an infection in the bloodstream which causes symptoms including muscle aches, chills and fever and some patients had to be hospitalized for treatment of the infection.

After the FDA recall was issued, the company voluntarily recalled all the syringes.  However, two workers pled guilty for their roles in shipping bacteria-tainted syringes that prosecutors blamed for five deaths and hundreds of infections. 

Plant manager Aniruddha Patel, and quality control director Ravindra Kumar Sharma, were sentenced to more than four years in prison for fraud and allowing tainted drugs into the marketplace. The company's chief executive, Dushyant Patel, was indicted on 10 charges including fraud and selling adulterated medical devices.

Prosecutors said the company shipped heparin- and saline-filled syringes contaminated with bacteria to hospitals and clinics in Colorado, Florida, Illinois and Texas.