Nurse Assist Sterile Water and Saline Recalled Following FDA “Do Not Use” Warning
Federal regulators are warning consumers to avoid recalled sterile water-based medical products manufactured by Nurse Assist, LLC, which may pose serious or life-threatening infection risks to patients, due to potential bacterial contamination.
The U.S. Food and Drug Administration (FDA) announced the Nurse Assist sterile water and saline recall on November 6, indicating the manufacturer found the packaging seal may potentially break and compromise the sterile barrier, which can introduce harmful bacteria into the solution. To date, there have not been any reports of adverse events in relation to the products.
Officials issued an FDA advisory on the same day of the recall announcement, warning consumers to avoid the potentially tainted and nonsterile Nurse Assist manufactured saline and sterile water medical products, which can cause severe or deadly bloodstream, urinary tract, respiratory, open wound, or soft tissue infections.
The FDA warned that elderly or critically ill patients, and those with weakened immune systems or chronic diseases, are especially at risk of sustaining serious health consequences after exposure to contaminated water-based medical solutions, which are meant to be free of any germs or bacteria.
Nurse Assist Sterile Water and Saline Recall
The recalled medical products are prepackaged sterile water and sterile salt water solutions used in health care settings to clean or flush wounds or medical tubing, such as intravenous (IV) or urinary catheters.
The recall includes 0.9% sodium chloride irrigation USP products distributed in 100 mL, 250 mL, 500 mL, and 1000 mL bottles, 3.1oz and 7.1oz spray cans, 3mL, 5mL, and 10mL syringes, as well as, sterile water for irrigation USP products sold in 100 mL, 250 mL, 500 mL, and 1000 mL bottles, 120 mL cups, 10mL and 30mL syringes. The products were distributed individually and in repackaged medical convenience kits nationwide and in Canada under several different brands, including Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire.
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FDA officials urge consumers and medical professionals to avoid using the potentially nonsterile solutions. The agency indicates it is currently working with Nurse Assist on the bacterial contamination issue, and will update consumers if new or additional information becomes available.
Customers can expect a notification letter and electronic communication from Nurse Assist, with instructions on how to arrange for return and replacement of their recalled products. For more information, consumers may contact Nurse Assist, LLC by phone at 800-649-6800 on Monday through Friday, between the hours of 8:00 am and 4:30 pm (CST), or by e-mail at firstname.lastname@example.org.
The FDA also urges consumers to report any adverse reactions they experienced after using the products to the FDA MedWatch Adverse Reporting program.
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