Nurse Assist Inc. announced a recall of 386,175 Normal Saline Flush IV Syringes due to possible Burkholderia Cepacia contamination. The Food and Drug Administration (FDA) has identified this as a Class I recall, indicating the most serious type of recall.
The B. cepacia bacterium can cause bloodstream infections particularly in patients with weakened immune systems. Effects of B. cepacia infection can range from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis. Use of contaminated products may lead to serious adverse health consequences, including bloodstream bacterial infections and death.
The 12mL IV Normal Saline Flush Syringe is supplied as a 3mL, 5mL, or 10mL fill volume. This recall affects all lots of product codes 1203, 1205, 1210, and 1210-BP. The syringes were manufactured between September 24, 2015 to August 1, 2016 and were distributed between February 16, 2016 and September 30, 2016. All affected providers and patient groups should immediately discontinue the use of any recalled products.
The Normal Saline Flush contains 0.9% Sodium Chloride and is used to clear out medical devices that deliver medicine directly into the patient’s veins through a needle or catheter. These syringes are used by health care providers prior to and after a drip medication is connected to a patient.
For more information call (800) 649-6800 or visit NurseAssist.com.