In January, the Food & Drug Administration (FDA) issued a Class I Recall for Normal Saline Flush syringes made by Nurse Assist Inc. The syringes have shown a direct link to an antibiotic-resistant bacterial infection known as Burkholderia Cepacia (B. Cepacia). According to the Centers for Disease Control, B. Cepacia is not threatening when otherwise healthy patients are infected. For those patients with compromised immune systems, the infection can develop into a severe respiratory illness, making it particularly dangerous for those who have lung diseases such as cystic fibrosis. The infection arises from soil and water exposed to B. Cepacia and spreads through person-to-person contact, making it hard to contain in healthcare environments such as hospitals and nursing homes.
Saline flush syringes are used after medication is delivered through an IV in order to keep the entry point sterile and prevent infection. The introduction of an infection such as B. Cepacia can have serious consequences.
Below are the product specifics, as listed on FDA.gov:
- Product Name: Normal Saline Flush
- Product Description: 12 mL IV Flush Syringe with a 3 mL, 5 mL, or 10 mL fill volume
- Product Codes: All lots of product codes: 1203, 1205, 1210 and 1210-BP
- Manufacturing Dates: September 24, 2015 to August 1, 2016
- Distribution Dates: February 16, 2016 to September 30, 2016
- Devices Recalled in the U.S.: 386,175 syringes nationwide
If you or a loved one were a patient in a hospital, nursing home or other healthcare facility and suffered injuries from a B. Cepacia infection, please contact the product liability attorneys at Levin & Perconti to see if you have a case. Consultations are free.