Do Not Use Certain Saline and Sterile Water Medical Products (2024)

Español

Date Issued: November 6, 2023

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 e-mail 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 below.

Device Description

Water-based medical products include sterile saline (0.9% sodium chloride) and sterile water medical products used for irrigation or flushing of wounds or medical tubing (such as intravenous (IV) catheters and urinary catheters). Water-based products may also be used for other medical purposes.

Products May Not Be Sterile

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/soft tissue, and respiratory infections.

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

To date, the FDA is not aware of reports of adverse events associated with the use of these recalled products.

FDA Actions

The FDA will continue to work with Nurse Assist, LLC to help ensure that the public is notified to stop using the recalled products.

The FDA is monitoring reports of problems with water-based medical products manufactured by Nurse Assist, LLC.

The FDA will continue to keep the public informed if new or additional information becomes available.

Affected Products

Product information provided by the company, including Unique Device Identifier (UDI), is in the table below.

The recalled products have these expiration dates:

• November 1, 2023 - September 18, 2025 (all products, except for 1030A)
• November 1, 2023 - September 18, 2028 (part number 1030A)

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).

Related Additional Recalls (Updated 4/15/2024):

Reporting Problems to the FDA

If you think you had a problem with these recalled products, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.