Federal drug regulators indicate that a Normal Saline Flush IV Syringe recall has been categorized as a Class I recall, suggesting that continued use may pose a serious risk of injury or death for patients.
A saline flush syringe recall was issued on October 5, 2016, affecting nearly 400,000 units distributed across the U.S., which could be contaminated with Burkholderia Cepacia and cause a serious bloodstream infection that often results in death.
On Tuesday, the FDA upgraded the action to a Class I recall, the most serious classification. The recall was upgraded because it involves products that have the potential to cause serious harm, adverse side effects or even death to patients who are affected.
The recall was upgraded after incidents of Burkholderia Cepacia bloodstream infections were reported to the FDA. Burkholderia cepacia (B. cepacia) is a complex bacteria that can cause bloodstream infections, especially in patients with weak immune systems. It is often found in soil and water and is resistant to many common antibiotics.
B. cepacia can be an especially serious infection to patients with cystic fibrosis, causing death. Symptoms of Burkholderia cepacia vary widely from no symptoms whatsoever to serious respiratory infections.
The Normal Saline Flush IV Syringe recall includes the 12 mL IV Flush Syringe with 3 mL, 5 mL, or 10 mL fill volumes. It is a plastic syringe filled with 0.9% percent sodium chloride and is used to clear out medical devices that deliver medicine directly to a patient’s vein through a needle or catheter. They are also used before and after a drip medication is connected to a patient.
Nurse Assist Inc. advised customers to stop using the syringes, complete the medical device recall return response form and return any affected products to the company.
The Normal Saline Flush IV Syringes recalled included unexpired items from all lots of product codes 1203 in 3 mL sizes, 1205 in 5 mL sizes, 1210 in 10 mL sizes, and 1210-BP in 10 mL sizes that were manufactured between September 24, 2015, to August 1, 2016.
The products were packaged 30 syringes to an inner carton and six inner cartons in a case, totaling 180 syringes. Product 1210-BP was packaged with 400 syringes to a case. The syringe products were distributed February 16, 2016, to September 30, 2016.
The FDA warns consumers and healthcare providers to report any adverse side effects as a result of the Normal Saline Flush IV Syringe recall to the FDA’s MedWatch Adverse Event Reporting Program and to contact Nurse Assist Customer Service at 800-649-6800 ext 10 to return the affected items.