Sierra, Heparin and Saline Syringes Contamination Recall
January 21st 2008 | NEWSInferno
More Sierra Pre-Filled Syringes have been recalled due to concerns over potential bacterial contamination. The Sierra Pre-filled Syringe recalls has now been expanded to include all lots and all sizes of both Heparin and Saline pre-filled flushes manufactured by Sierra Pre-Filled, Inc.—also known as AM2 PAT—located in Angier, North Carolina.
The Sierra Pre-Filled syringe products are distributed under two brand names: Sierra Pre-Filled Inc. and B. Braun. The 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. Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines. 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.
One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes is confirmed to be contaminated with the Serratia marcescens bacteria and resulted in a number of patient infections. Infections resulting from this bacteria can cause fever and chills and can be serious, but generally respond well to antibiotics; however, this type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
An ongoing Food and Drug Administration (FDA) inspection of Sierra Pre-Filled’s facility revealed that 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.