Why are Nurse Assist syringes being recalled?
In the medical device context, “recall” means removal of a product from the market. There are two types of recalls: voluntary, and mandatory.
A voluntary recall is when a product’s manufacturer decides on its own to remove a distributed product from the market. Manufacturers usually only voluntarily recall a product when they think it doesn’t comply with Federal Drug Administration (FDA) standards. A voluntary recall is only considered a “recall” by the FDA if the product actually violates FDA standards.
On October 4, 2016, Nurse Assist issued a voluntary recall of I.V. Flush Syringes from specific lots. The voluntary recall instructs customers not to use I.V. Flush Syringes from specific lots. It also instructs manufacturers to ship the I.V. Flush Syringes back to Nurse Assist. Nurse Assist says it will provide customers and manufacturers with credit, presumably redeemable for future purchases of Nurse Assist merchandise.
Nurse Assist, Inc. I.V. Flush Syringes are infecting patients with Burkholderia cepacia, a sometimes fatal bacteria. The people affected by this bacterial infection outbreak are patients using syringes manufactured by Nurse Assist of Haltom City, Texas, as well as Nurse Assist itself. As of November 16, 2016, 151 patients have been infected by Nurse Assist syringes at 58 different facilities. All of these infected patients are from the U.S. East Coast. The state with the most reported Burkholderia cepacia syringe infections is New York, with 55. The majority of those infected are long-term care patients who are using IVs or central venous catheters.
What is Burkholderia cepacia bacterium?
“Infection” means invasion by a virus or bacteria. The specific bacteria infecting patients here is called Burkholderia cepacia. Burkholderia cepacia attacks humans, onions, and tobacco plants. Burkholderia cepacia has different effects on different patients. Some patients experience no symptoms from a Burkholderia cepacia infection. In other patients, Burkholderia cepacia causes fever, chills, clammy skin, disorientation, shortness of breath, increased heart rate, and even death.
Why is it dangerous?
Because these Burkholderia cepacia infections are most likely being caused by syringe needles, the infection affects the patient’s blood cells. Not only can Burkholderia cepacia spread through the use of infected syringes, but it can also spread person-to-person. The bacteria can be resistant to many forms of antibiotics, making it difficult to treat. Its eradication generally requires the patient to take multiple antibiotics. Patients with hemoglobinopathies (a genetic blood disease) and patients with preexisting lung infections (like cystic fibrosis) are at higher risk of infection from Burkholderia cepacia. As of November 16, 2016, six patients infected with the bacteria have died.
Contact Us – Defective Device Attorneys
If you have recently used an IV or central venous catheter, and are experiencing any of the mentioned symptoms, contact your doctor. You may be infected with Burkholderia cepacia. If you are unsure whether you used an I.V. Flush Syringe, this link shows what the wrapper on the outside of the container looks like. Remember: medical devices harm patients all the time. If you suspect you’ve been injured by a medical device, contact your doctor to make sure everything is functioning properly. If you realize you’ve been injured by a medical device please call the defective medical device attorneys at GoldenbergLaw.