Government health officials have announced a major recall for certain IV flush syringes, due to a risk that they may be contaminated with dangerous bacteria that could cause serious and potentially fatal infections, especially among the elderly and those with weakened immune systems.
A Nurse Assist I.V. Flush Syringe recall was announced by the FDA on October 4, following several reports that indicate patients developed Burkholderia cepacia bloodstream infections after receiving saline flushes from prepackaged syringes. To date, no serious injuries or deaths have occurred from the use of the products.
The recalled syringes are prepackaged saline flushes used in a healthcare setting to administer intravenous treatments, clearing central or arterial lines of any medicine or perishable liquids that could pose a sterilization hazard.
Burkholderia cepacia is a group of complex bacteria that can be found in soil and water and is often resistant to many common antibiotics, posing an increased risk to those with weakened immune systems such as children and the elderly.
Although the bacterial infection poses no significant threat to healthy individuals, those with respiratory infections, specifically cystic fibrosis and chronic lung disease may be more susceptible to the bacteria and require immediate medical treatment.
The FDA has announced all unexpired lots of the Nurse Assist saline flush syringes are included in the recall until a thorough investigation by the FDA and the manufacturer can determine the source of the contamination and specifically pinpoint impacted lots.
Included in the recall are all unexpired Nurse Assist I.V. Flush Syringe products that were distributed to customers and distributors between February 16, 2016 and September 30, 2016. The recalled products were sold in 3ml sizes with Product Code 1203, 5ml sizes with Product Code 1205, 10ml sizes with Product Code 1210, and 10ml sizes with Product Code 1210-BP. Product Numbers 1203, 1205, and 1210 were packaged 30 syringes to an inner carton and six inner cartons in a case totaling 180 syringes. Product Number 1210-BP was packaged with 400 syringes to a case. Customers may identify the recalled product code and lot code information by checking the syringe label.
Customers are being asked to stop using the recalled syringe products immediately and return them to Nurse Assist for a credit by contacting Nurse Assist Customer Service at 1-800-649-6800 ext. 10. Nurse Assist Inc. has announced customers and distributors are being notified through email, phone, and certified mail with instructions for returning the product.