Lawsuits Filed Against Manufacturer of Recalled Syringes

January 2008

UPDATE – Five people have filed a lawsuit against Seirra Pre-Filled, Inc., alleging that they became seriously ill and were hospitalized as a result of the company’s contaminated pre-filled heparin syringes.

The U.S. Food and Drug Administration recalled the syringes last week after they were found to be contaminated with Serratia marcescens bacteria. Infections resulting from S. marcescens can cause fever and chills and can be serious, but generally respond well to antibiotics. This type of bacterial infection can lead to life-threatening injuries and/or death in people with weakened immune systems.

Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems. The product was distributed to Florida, Texas, Illinois, Colorado, and Pennsylvania.

ORIGINAL ALERT – The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of all sizes and strengths of Heparin and Saline pre-filled flushes manufactured by AM2 PAT, Inc. of Angier, North Carolina. The pre-filled syringes are contaminated with Serratia marcescens, which has resulted in patient infections.

Bacterial infections caused by Serratia marcescnes can lead to serious health problems resulting in life-threatening injuries and/or death. The contaminated flushes were sold under two brand names, Pre-Filled Inc. and B. Braun.

An ongoing inspection conducted by the FDA has revealed that AM2 PAT, Inc.’s facility is not in compliance with Quality System regulation and does not meet standards to ensure the sterility of its pre-filled syringes.