FDA Warns Public of Contaminated Syringes Manufactured by AM2 PAT, Inc. Containing Heparin and Saline Pre-filled Flush Syringes

The U.S. Food and Drug Administration (FDA) announced on January 25, 2008, 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 have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death, and have in fact caused blood infections in patients. These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor.

Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA. The recall affects all lots of these products.

The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes. Serratia marcescens, a bacterium found in water and soil, has been linked to pneumonia, blood infections, and urinary tract and wound infections.

AM2 PAT, Inc. voluntarily recalled these products on January 18 after confirming bacterial contamination in some user samples. MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C. PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes Normal Saline IV Flush Solution USP, All Strengths and Sizes Blood infections resulting from use of syringes was in the news months back when the New York State Health Department announced that it was contacting patients of Dr. Harvey Finkelstein and urging them to be tested for Hepatitis B and C and HIV because he was re-using syringes on different patients. It was reported this past week that the State had been sued by one of his patients alleging that the Health Department improperly delayed notifying Dr. Finkelstein’s patients about his unsanitary practices after it became aware of the problem.

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