FDA Warns Public of Contaminated Syringes
The U.S. Food and Drug Administration 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 have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. AM2 PAT manufactured the syringes 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, FDA says. 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, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes. Traditionally, the bacterium is found in water and soil and has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections, FDA says.
AM2 PAT voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples. FDA posted a public warning Friday. Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST. For a complete listing of the products recalled, including their NDC and catalog numbers, visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01785.html.
Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.