Class 1 Recall: Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.
Reason for Recall
Nurse Assist Inc. is recalling the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.
According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people "vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis."
The use of affected products may cause serious adverse health consequences including bloodstream bacterial infections and death.
Who May be Affected
What to Do
On October 5, 2016, Nurse Assist, Inc. sent a certified mail notification to all affected customers. The notice asked customers to:
Customers with questions are instructed to contact Nurse Assist Inc. by telephone at 1-800-649-6800 ext. 10, Monday through Friday, between the hours of 8am and 5pm, Central Time. Consumers may also contact the company via email at ProductRemovalInfo@nurseassist.com.
Date Recall Initiated:
October 4, 2016