Do Not Use Certain Brands of Saline and Sterile Water Medical Products From Nurse Assist Because They May Not Be Sterile, FDA Warns

November 06, 2023

On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced (https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-brands-saline-and-sterile-water-medical-products-nurse-assist-because-they-may) 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) and warned consumers, healthcare providers, and healthcare 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, because they may not be sterile.

FDA update

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:

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

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:

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.


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