Sierra Pre-Filled Heparin Syringes Recalled After FDA Inspection Finds Problems with Company’s Quality SystemDec 25, 2007 | Parker Waichman LLP
Sierra Pre-Filled Heparin Syringes have been recalled by the Food & Drug Administration (FDA) after it was discovered that the medical devices were contaminated with dangerous bacteria. The Centers for Disease Control and Prevention (CDC) is also investigating dozens of blood infections linked to the Sierra Pre-Filled Syringes contaminated with bacteria. In announcing the Sierra Pre-Filled Syringe recall, the FDA said that an ongoing inspection of Sierra Pre-Filled showed that the firm is "not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes".
Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported. Of the 20 Rush outpatients who fell ill, 14 required hospitalization. Although all responded quickly to antibiotic treatment, one patient remains hospitalized as of Tuesday, said Dr. John Segreti, hospital epidemiologist.
Doctors at Rush were able to trace the infections to heparin-filled Sierra Pre-Filled Syringes the patients used during home treatment for cancer and other ailments. Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines. The infections were caused by bacteria found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled. The infections were caused by a bacterium called Serratia marcescens (pronounced Sur-AY'-she-uh mar-SUH'-sens). Syringes from that batch were also sent to Colorado, Florida, and Pennsylvania but infections—so far—have turned up only in Illinois and Texas, said Dr. Arjun Srinivasan of the CDC. The infections can cause fever and chills and can be serious but generally respond well to antibiotics.
The Sierra Pre-Filled Syringe recall includes the company’s Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes; lot number: 070926H; NDC number: 64054-1003-02; Catalog number: 1003-02. The CDC is working to ensure doctors are alerted about the contamination; doctors and hospitals should be aware that more cases could surface. The FDA is asking doctors are advised to trace the recalled Sierra Pre-Filled Syringes and make sure their patients stop using them at once. The contaminated Sierra Pre-Filled Syringes should be put into "quarantine" and returned to the distributor.
Heparin is the same drug linked to recent overdoses accidentally given to actor Dennis Quaid's newborn twins. In that case, the heparin was made by Deerfield, Illinois-based Baxter Healthcare Corporation. The overdoses given to the Quaid twins were a result of the babies being dosed with medication from the 10,000 unit vials used for adults and not the 10 unit vials for babies. Also this year, an alert was issued after three infants died in Indiana after they were mistakenly given adult doses of heparin. Six other newborns received an overdose and were not among the first to be affected in this sort of mix-up, apparently also happening back in 2001 when two patients were given incorrect dosages of the drug. Both the 10,000 unit adult vials and the 10 unit baby vials of heparin bear similar packaging which seems to be at the root of under and overdosing errors.