Heparin Syringes Recalled Due To Contamination

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Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Medical Devices / Diagnostics
Article Date: 24 Dec 2007 - 6:00 PDT

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The US Food and Drug Administration (FDA) announced late last week that a medical device company has issued a nationwide recall of one lot of pre-filled heparin IV flush syringes because they are contaminated with a potentially life-threatening bacteria called Serratia marcescens.

Some 40 patients have become infected in Texas and Illinois, with no deaths reported and several hospitalizations. The US Centers for Disease Control and Prevention (CDC) has confirmed the presence of the bacteria in several unopened syringes.

Some of the infected patients were being treated at Rush University Medical Center in Chicago as outpatients. Doctors there traced the infections to heparin-filled syringes used to clear out catheters and intravenous lines, for instance in cancer treatment.

The syringes are made by a subsidiary of the pharmaceutical company Am2pat Inc (who also trade as Salient Hct), called Sierra Pre-Filled, who are based in Angier, North Carolina.

The syringes are also used by patients at home, and doctors are advised to trace the recalled products, and make sure their patients stop using them at once. The product should be put into "quarantine" and returned to the distributor.

The product is called: 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.
Manufacturer: Sierra Pre-Filled.

The product was distributed all over the US, and the FDA alert mentions the following states in particular: Florida, Texas, Illinois, Colorado, and Pennsylvania.

The FDA said that an ongoing inspection of the medical device company 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".

The manufacturer is working with the FDA and the CDC to keep on top of the situation, said the FDA.

The recall is not linked to several recently reported incidents of heparin overdoses accidentally given to children, including the newborn twins of film actor Dennis Quaid.

Click here for more information on this recall (FDA).

Sources: NEWSInferno, FDA.

Written by: Catharine Paddock

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