Sierra Pre-Filled Syringe Recall ExpandedJan 21, 2008 | Parker Waichman LLP 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.
This is not the first time Sierra Pre-Filled has been in the news in recent weeks. The CDC began its investigation following reports of dozens of blood infections linked to contaminated medical syringes. Around 40 people were sickened in Texas and Illinois, including 20 outpatients at the Rush University Medical Center in Chicago; no deaths were reported. Of the 20 Rush outpatients who fell ill, 14 patients required hospitalization. Doctors at Rush were able to trace the infections to heparin-filled syringes the patients used during home treatment for cancer and other ailments.
A leukemia patient—Katie Abrams, 30, of Buffalo Grove, Illinois—also filed a suit against Sierra Pre-Filled, Inc. when she claimed a batch of Sierra Pre-Filled heparin syringes contaminated with bacteria made her fall violently ill. Abrams was hospitalized for nine days after using the Sierra Pre-Filled Syringes at home, when she "became ill with uncontrollable shaking, vomiting and a fever that reached as high as 105.5 degrees Fahrenheit," according to the complaint filed recently in that state’s court.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.