Nurse Assist, LLC, is recalling (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nurse-assist-llc-issues-recall-09-sodium-chloride-irrigation-usp-and-sterile-water-irrigation-usp) the following water-based medical products:

• 0.9% sodium chloride irrigation USP (100 ml bottles, 250 ml bottles, 500 ml bottles, 1000 ml bottles, 3.1 oz spray cans, 7.1 oz spray cans, 3 ml syringes, 5 ml syringes, and 10 ml syringes)
• Sterile water for irrigation USP (100 ml bottles, 250 ml bottles, 500 ml bottles, 1,000 ml bottles, 120 ml cups, 10 ml syringes, and 30 ml syringes)

The products were sold under the Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire brands. The recalled products may be available as individual units or may be included as part of a kit.

FDA Recommendations for Consumers, Healthcare 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 determine whether you have the recalled (#Products) products at home or in your healthcare facility’s inventory, whether as individual units or included as part of a kit.
• Stop use of the recalled products and follow the recommendations in Nurse Assist, LLC’s, recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nurse-assist-llc-issues-recall-09-sodium-chloride-irrigation-usp-and-sterile-water-irrigation-usp) announcement.
• Contact Nurse Assist, LLC, at 800-649-6800, Monday–Friday from 8 am–4:30 pm CT or productremovalinfo@nurseassist.com (mailto:productremovalinfo@nurseassist.com) with any questions.
• Report any problems with the products by Nurse Assist, LLC, to FDA as outlined later below.

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound or soft tissue, and respiratory infections, FDA said (https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-brands-saline-and-sterile-water-medical-products-nurse-assist-because-they-may).

Older adult patients or those who are critically ill, have weak immune systems (including newborn infants, pregnant women, and patients with cancer), or have chronic diseases are particularly at risk for infection. However, other patients could also develop infections after they are exposed to contaminated water-based medical products.

To date, FDA said that is not aware of any reported adverse events associated with the use of the recalled products.

FDA Actions

FDA said that (https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-brands-saline-and-sterile-water-medical-products-nurse-assist-because-they-may) it is working with Nurse Assist, LLC, to ensure that the public is notified to stop using the recalled products. The agency is monitoring reports of problems with water-based medical products manufactured by Nurse Assist, LLC, and will continue to keep the public informed of any new or additional information.

Affected Products

FDA shared product information provided by the company, including Unique Device Identifier (#UDI) (UDI), in a table in its announcement (https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-brands-saline-and-sterile-water-medical-products-nurse-assist-because-they-may).

The recalled products have the following expiration dates:

• November 1, 2023–September 18, 2025 (all products except 1030A)
• November 1, 2023–September 18, 2028 (product number 1030A)

Reporting Problems to FDA

If you think you’ve experienced a problem with the recalled products or any medical device, report the problem through FDA’s MedWatch Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).

Healthcare personnel working in facilities that are subject to FDA's user facility reporting requirements (https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities) should follow their facility’s established reporting procedures.