B. Braun Pays Roughly $8 million in Contaminated Saline Case
B. Braun has agreed to pay $8 million to settle a criminal case involving contaminated saline syringes.
About the Contaminated Saline Case
B. Braun medical launched a nationwide voluntary recall of their saline syringes after being contaminated with Serratia marcescens bacteria. The syringes infected people in California, Texas, New York, and Nebraska.
This was just a little after Braun had already recalled syringes due to a new radiation sterilization process that had gone wrong. Acknowledging that they were at fault, Braun has agreed with the non-prosecution agreement to pay $7.8 million in order to avoid criminal charges.
The company now has to agreed to hire an independent compliance auditor and increase its oversight of 3rd party contractors.
Signs of Previous Complications
According to MassDevice, Braun bought the contaminated syringes from a company called Am2Pat, despite knowing beforehand of manufacturing problems at the North Carolina plant where the syringes were made, federal prosecutors said.
After the recall due to sterilization problems, Braun continued buying the syringes from Am2Pat, eventually leading up to the bacteria contamination that infected victims across the country.
In 2008, Am2Pat’s directors and managers faced criminal charges which resulted to months in jail. The company’s CEO fled the country and is now on the FBI’s most wanted list.