FDA Warns Public of Contaminated Syringes
The Food and Drug Administration (FDA) today 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.
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 healthcare facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Healthcare 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 healthcare providers know that they have been exposed to syringes recalled by the 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 Centers for Disease Control and Prevention (CDC) has confirmed growth of Serratia marcescens from unopened heparin syringes.
Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.
The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.
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, Md. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
Source: FDA
Â
Getting Down and Dirty With PPE: Presentations at HSPA by Jill Holdsworth and Katie Belski
June 26th 2025In the heart of the hospital, decontamination technicians tackle one of health care’s dirtiest—and most vital—jobs. At HSPA 2025, 6 packed workshops led by experts Jill Holdsworth and Katie Belski spotlighted the crucial, often-overlooked art of PPE removal. The message was clear: proper doffing saves lives, starting with your own.
Spring Into Safety: How Seasonal Deep Cleaning Strengthens Hospital Infection Control
June 13th 2025Rooted in ancient rituals of renewal, spring-cleaning has evolved from cultural tradition to a vital infection prevention strategy in modern hospitals—one that blends seasonal deep cleaning with advanced disinfection to reduce pathogens, improve air quality, and protect patients.
