Lawsuits on Sierra Pre-Filled Syringes rock North Carolina. Sierra Pre-Filled bacteria tainted syringes continue to be the target of lawsuits. Five people filed a lawsuit Thursday against Sierra Pre-Filled of Angier, North Carolina, manufacturer of the contaminated pre-filled syringes. All five claimants are Illinois residents and patients at Rush University Medical Center in Chicago.
The five Sierra Pre-Filled syringe lawsuit plaintiffs allege they became seriously ill and were hospitalized because of the Food and Drug Administration (FDA) and Sierra Pre-Filled announced an expansion of the recall to include all lots and sizes of the heparin and saline pre-filled syringes because they were tainted with the bacteria Serratia marcescens.
Sierra Pre-Filled syringe products are distributed under two brand names
The Sierra Pre-Filled syringe products are distributed under two brand names: Sierra Pre-Filled Inc. and B. Braun and products are sold in pre-filled syringes in 3 ml and 5 ml sizes for Heparin and in 3 ml, 5 ml, and 10 ml sizes for Normal Saline.
Consumers and user facilities with the Sierra Pre-Filled recalled pre-filled syringes or Heparin or Saline Lock Flush Solution USP, should stop using the products immediately. Recalled products should be immediately quarantined in inventory and immediately returned to the distributor. The product was distributed to Florida, Texas, Illinois, Colorado, and Pennsylvania.
Infections resulting from the Serratia marcescens can cause fever and chills and can be serious, but generally respond well to antibiotics. In people with weakened immune systems, however, this type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
Many of those using the tainted Sierra Pre-Filled syringes were undergoing chemotherapy treatments which would have compromised their immune systems.
An ongoing FDA inspection of Sierra Pre-Filled’s facility revealed the company is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.