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Drug & Device News

By ALM Staff | Law Journal Newsletters |

Employees Plead Guilty to Charges Company Misbranded Medical Devices

Two employees of AM2PAT Inc., which manufactured pre-filled syringes containing heparin and saline, have pleaded guilty to various charges stemming from the shipment of the company's products, which were misbranded as “sterile.” The company did not, in fact, test the syringes for sterility. Once they were shipped, the company then falsified device history reports to make it appear that sterility testing had been accomplished on the syringes prior to shipment. According to the U.S. Attorney's release announcing the guilty pleas, as a result of the scheme “between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT, Inc. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.”

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