Monday, November 6th, the U.S. Food and Drug Administration (FDA) issued a Safety Communication 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.
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.
This Safety Communication provides:
- Information on recalled products.
- Recommendations for consumers, health care providers, and health care facilities.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with water-based medical products to the FDA.
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).