(WHNT) – The U.S. Food and Drug Administration is warning consumers not to use certain brands of sterile water medical products because they “might not be sterile.”
According to the FDA, saline and sterile water medical products of various brands manufactured by Nurse Assist, LLC, may not be sterile and could potentially be contaminated with bacteria, which could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections.
The following products are being pulled due to the fact they might 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 have been sold under the following brands and may have been sold separately or as a part of a kit:
- Nurse Assist
- Cardinal, Covidien
- Halyard Owens Minor
- Idexx, Mac Medical
- McKesson
- Medichoice Owens Minor
- Medline
- Sol
- SteriCare
- Trudell
- Vyaire
Patients who are elderly, critically ill, have chronic diseases or have weak immune systems (including infants, pregnant women and cancer patients) are particularly at risk of infection.
The FDA said it is not aware of any reports of adverse reactions associated with the use of these products.
If you have any questions about this recall, contact Nurse Assist by phone, at 800-649-6800 Monday through Friday from 8:00 a.m. to 4:30 p.m. (CST).
For any additional information, or to check the Unique Device Number of your Nurse Assist product, click here.
