Pennsylvania-based medical device maker B. Braun will pay up to $7.8 million to resolve criminal charges stemming from its 2007 sale of contaminated saline syringes that prosecutors said caused an outbreak of bacterial infections and led to five deaths.
B. Braun Medical agreed to pay $4.8 million in penalties and forfeiture and up to $3 million more in restitution, to resolve its criminal liability for the sale of contaminated pre-filled saline flush syringes.
The syringes were manufactured by AM2PAT in North Carolina and were contaminated with particulate matter stemming from a new radiation sterilization process in use at the plant.
\B. Braun announced a voluntary nationwide recall in July 2007, but then resumed buying syringes from AM2PAT that were subsquently found to be contaminated with Serratia marcescens bacteria, which can cause blood infections and infected patients in California, Texas, New York and Nebraska, prosecutors said.
In 2009, AM2PAT quality control director Ravindra Kumar Sharma and Aniruddha Patel, AM2PAT's plant manager, both pleaded guilty to conspiracy to commit a number of federal offenses, including felonies. Each was sentenced in 2009 to 54 months in prison.