Don’t Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile

 

To: Healthcare Facilities, Agencies and Organizations From: Health Facilities and Emergency Medical Services Division The U.S. Food and Drug Administration (FDA) is warning consumers, health care providers, and health care facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands. On November 6, 2023, Nurse Assist, LLC announced a recall of the following water-based medical products because the products may not be sterile: 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes); Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes). These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire. The recalled products may be available as individual units or may be included as part of a kit. Recommendations for Consumers, Health Care Providers, and Facilities: Check your supply of saline (0.9% sodium chloride) and sterile water medical products (bottles, spray cans, cups, and prefilled syringes) to find out if you have any of the recalled products at home or in your health care facility’s inventory. Do not use these recalled products and follow the recommendations in the company’s recall announcement. Be aware that these recalled products may be available as individual units or may be included as part of a kit. If you have questions about this recall, contact Nurse Assist, LLC by phone at 800-649-6800 Monday through Friday between the hours of 8:00 am and 4:30 pm (CST) or by email at productremovalinfo@nurseassist.com.  Report any problems with saline and sterile water medical products by Nurse Assist, LLC to the FDA. See Reporting Problems to the FDA. For a complete list of affected products and more details, visit the U.S. Food and Drug Administration information release.