The U.S. Food and Drug Administration (FDA) has issued a Class I recall for over 380,000 saline flush syringes after discovering the syringes were possibly contaminated with a dangerous bacteria. Manufactured by Nurse Assist Inc., the Normal Saline Flush IV Syringes are contaminated with Burkholderia cepacia, a bacteria more commonly known as B. cepacia.
According to the FDA, Normal Saline Flush IV Syringes are most commonly used to “clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter.” This makes the syringes useful in a wide variety of applications. With the widespread use of the syringes, potential contamination puts many patients at risk, particularly those with weakened immune systems.
B. cepacia can occur naturally in soil and water, but certain strains can also be found in hospitals and healthcare facilities. This type of bacteria is dangerous for patients because it is resistant to many antibiotics normally used to treat infections. Because the syringes are used specifically with IVs, the bacteria is causing bloodstream infections. Symptoms of B. cepacia include fever, chills, clammy skin, confusion, shortness of breath, and increased heart rate, among others. Additionally, B. cepacia can cause patients to suffer severe respiratory infections.
The FDA is working with the Centers for Disease Control and Prevention (CDC) to monitor reported contaminations. The FDA and CDC received reports of B. cepacia infections from contaminated syringes from hospitals and healthcare facilities in Delaware, Maryland, New Jersey, New York, and Pennsylvania, including 160 infections and 7 deaths since August 2016. The FDA and the CDC are still working to determine if the deaths were caused by the B. cepacia infection or some other health condition.
The FDA advised healthcare facilities to immediately discontinue use of Normal Saline Flush IV Syringes and report any suspected infections to the agency.