A voluntary recall has been initiated by Nurse Assist. All unexpired lots of IV Flush Syringes have been potentially linked to bloodstream infections from Burholderia cepacia.
A voluntary recall has been initiated by Nurse Assist. All unexpired lots of IV Flush Syringes have been potentially linked to bloodstream infections caused by Burholderia cepacia, a group of bacteria found in soil and water. Infections from B. cepacia are often resistant to common antibiotics according to the Centers for Disease Control and Prevention (CDC).
According to the recall alert issued by the US Food and Drug Administration (FDA), “Nurse Assist voluntarily recalled its IV Flush Syringes after becoming aware of patients that developed Burkholderia cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist.”
Infections from B. cepacia pose little risk to healthy people. However, there is higher susceptibility in people with certain health issues. Those with immunodeficiency or chronic respiratory diseases such as cystic fibrosis are especially vulnerable. The infection can be transmitted through person-to-person contact, exposure to B. cepacia in the environment, and contact with contaminated surfaces.
Transmission is most often reported from contaminated medicines and medical devices. In 2005, the CDC identified clusters of pneumonia and other infections stemming from B. cepacia associated with contaminated mouthwash. In July of this year, 53 cases in 5 states were linked to liquid docusate sodium products. The CDC emphasizes diligence with infection control procedures. Due to its resistance to antibiotics, treatment of infections should be made on a case-by-case basis.
In the recall statement, Nurse Assist said, “Patient safety is of utmost importance, all unexpired lots of these products are being recalled until a thorough investigation can be completed. There are no other related recalls for Nurse Assist products.” A full list of the products effected, including lot numbers, can be found on the FDA, Recalls, Market Withdrawals, & Safety Alerts website.
All lots being recalled were distributed between February 2 and September 30, 2016. Nurse Assist is currently working to notify its distributors. They are also asking customers not to use any of the products from the recalled lots and to return them for credit instead.
Healthcare professionals reporting adverse reactions or quality issues regarding the use of this product should go to the FDA MedWatch Adverse Event Reporting program.