Company Accused of Shipping Unsterilized Syringes, Killing Five and Infecting Hundreds

A North Carolina medical device maker is accused of shipping unsterilized syringes used to deliver the blood-thinner Heparin and saline, causing at least five patient deaths and hundreds of life-threatening bacterial infections.

AM2PAT Inc. skipped sterilization tests on the products to save money and rushed shipments of untested syringes out to hospitals and health care facilities across the United States, officials said. The syringes were pre-loaded with Heparin and saline, two drugs commonly used to flush intravenous lines during treatments for cancer, kidney dialysis, and other medical procedures.

Tainted Syringes Linked to Injuries, Recalled

The company sold about $7 million worth of heparin and saline syringes between 2006 and 2007. As many as 300 patients across the United States suffered bacterial infections from contaminated AM2PAT syringes, officials said.

Some of those infected developed spinal meningitis and suffered permanent brain damage. Health inspectors have since traced the tainted syringes to infections in Colorado, Florida, Illinois, and Texas. Officials said many more people might have been infected by or died as a result of the contaminated syringes, but in some cases, a direct link to the cause of death could not be made.

CEO Flees Prosecution?

The syringes were recalled in 2007 after two former plant workers pleaded guilty to shipping contaminated syringes and helped prosecutors build a criminal case against the company’s CEO, Dushyant Patel. Patel’s whereabouts are unknown, but investigators suspect he may have fled to his native India to avoid prosecution. Patel was indicted on 10 criminal charges, including fraud, making false statements, and selling adulterated medical devices.

The workers, plant manager Aniruddha Patel, 43, and quality control director Ravindra Kumar Sharma, 54, were sentenced to over four years in federal prison for fraud and allowing tainted drugs into the marketplace.

AM2PAT is based in Chicago and had a subsidiary firm in North Carolina.

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