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ANGIER, N.C., Dec. 21 (UPI) -- The U.S. Food and Drug Administration said a group of pre-filled heparin syringes produced by AM2 Pat Inc. has been recalled due to contamination.
The recall of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot 070926H was announced Friday after the heparin IV flush syringes were found to be contaminated with Serratia marcescens.
The bacteria has resulted in patient infections, the company said in a release. The Centers for Disease Control confirmed growth of Serratia marcescens from several unopened syringes. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries or death.
The product was distributed nationwide, the company said.
The FDA said AM2 PAT's North Carolina facility is not in compliance with quality system regulations and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.
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