FDA Recalls Nurse Assist Saline Flush IV Syringes for Blood Infection Risk

FDA Recalls Nurse Assist Saline Flush IV Syringes for Blood Infection RiskAccording to the U.S. Food and Drug Administration (FDA), Nurse Assist, Inc. of Haltom City, Texas, has started a voluntary recall of its IV Flush Syringes due to incidents of Burkholderia cepacia, a potentially deadly bacterium that can cause infections in the bloodstream, especially in patients with already weakened immune systems.

According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of B. cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.”

The recall involves unexpired lots of the IV Flush Syringes distributed between Feb. 16, 2016, and Sept. 30, 2016. Nurse Assist said that it decided to initiate a voluntary recall after learning that some patients who had received intravenous care using the company’s I.V. Flush Syringes developed B. cepacia bloodstream infections.

The Nurse Assist IV Flush Syringes contain a 0.9% Sodium Chloride solution that is used to clear out medical devices that deliver medication directly into the veins of patients via a needle or catheter. According to the FDA, the use of the affected syringes could cause serious health consequences, including bloodstream bacterial infections and death.

State health agencies in Maryland, Pennsylvania and New Jersey reported a total of 33 cases of B. cepacia bloodstream infection associated with the Nurse Assist syringes. The Maryland Department of Health and Mental Hygiene reported that 11 cases of the bacterial infection were found in patients who had received care involving the Nurse Assist Syringes.

The Pennsylvania Department of Health reported 20 such cases and the New Jersey Department of Health reported that two residents had developed a bloodstream infection associated with the outbreak. Pennsylvania reported that its test on a sample of the Nurse Assist syringes revealed B. cepacia contamination.

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