Heparin and Saline Syringe Recall

On January 25, 2008, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots (one heparin and one saline) have been confirmed as contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. These syringes were distributed under the brand labels Sierra Pre-Filled, Inc. and B. Braun. A link to the January 25, 2008 recall is located below.

Have you been injured by a Heparin or Saline Syringe?

FDA Warns Public of Contaminated Syringes

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

This is the second recall related to contaminated flush syringes manufactured by AM2 PAT, Inc. On December 20, 2007, Am2Pat recalled one lot of pre-filled heparin flush syringes. A link to that initial recall is located below.

http://www.fda.gov/Safety/Recalls/default.htm

The initial recall was announced after a lot of heparin pre-filled syringes, lot number 070926H, was confirmed as being contaminated with Serratia marcescens. This lot of heparin pre-filled syringes was distributed nationwide, but primarily to Florida, Texas, Illinois, Pennsylvania, and Colorado. Injuries from infected syringes from this lot have been confirmed in Florida, Texas, and Illinois. The FDA inspected the facility where the syringes were manufactured and determined that the facility was “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.”

A month later, on January 25, 2008 AM2 PAT, INC., announced the recall of all lots of heparin pre-filled syringes ma and also all lots of saline pre-filled syringes manufactured by the company. These syringes were distributed under the Sierra Pre-Filled label and the B. Braun label. This expanded recall came after a second lot of syringes manufactured at the facility were confirmed contaminated with Serratia marcescens. The second confirmed contaminated lot was a lot of saline syringes with the lot number 070917A.

The recalled syringes may have different lot numbers than just the confirmed contaminated lots. However, the recalled syringes will bear the National Drug Code (NDC) prefix of 64054. These syringes were distributed to patients at in-patient facilities, out-patient facilities, and are frequently associated with home healthcare. If you have a potentially recalled syringe in your possession, do not use the product.

There have been many confirmed injuries associated with the contaminated syringes. Pre-filled syringes are usually used to flush out long-term intravenous (IV) lines, such as PICC lines or metaports. Therefore, these syringes are used in close contact with the blood stream. Serratia marcescens blood infections can result from such exposure to the blood stream. If you have used a contaminated syringe, you have experienced nauseau, fever, chills, vomiting, and other general signs of infection. These may be signs of a Serratia marcescens blood infection. A Serratia infection may respond well to antibiotics. However, some infections do not respond well to antibiotic treatment. As well, delays in treatment can create severe reactions. A Serratia marcescens infection can be severe and life threatening.

Florida Heparin Syringe Recall

State health officials have contacted hospital infection control professionals, county health departments, and eight distributors who serve the state. The distributors of the drug have voluntarily agreed to discontinue release of the drug and have contacted their clients who may have received tainted product. Individuals who may have used Sierra or B. Braun pre-filled heparin or saline flush syringes should immediately stop using the flush and contact their healthcare provider for a replacement supply and seek immediate medical attention if they develop a fever or other signs of an infection

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