Urgent FDA Recall: Saline and Sterile Water Products Alert
On November 6, 2023, the U.S. Food and Drug Administration (FDA) informed the public of a recall affecting certain brands of saline and sterile water products. This recall holds significant importance as it directly relates to the safety and welfare of consumers and healthcare providers alike. Let's look at details of the recall, including the affected products, the potential risks involved, and the essential measures that must be taken to protect consumers.
The Recall:
The U.S. Food and Drug Administration (FDA) has issued a warning regarding the sterility of some saline and sterile water medical products. These products are manufactured by Nurse Assist, LLC, and are sold under various brands, including Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, and more. The recalled products may be available as individual units or may be included as part of a kit. The product was distributed in the United States and Canada. Recalled Product was distributed from November 1, 2021 to September 18, 2023.
Impacted Products:
The recall affects the following products:
- 0.9% Sodium Chloride Irrigation USP
- Sterile Water for Irrigation USP
These products are available in different bottle sizes, spray cans, and syringe volumes. Please check your saline and sterile water supplies for the specific product names and sizes mentioned above. More information, including the Unique Device Identifier (UDI) can be found here: Affected Sterile Products
Potential Risks:
The use of nonsterile water-based medical products can pose serious health risks. Contaminated products could potentially harbor bacteria, leading to severe and even life-threatening infections. Infections that could arise include bloodstream, urinary tract, open wound/soft tissue, and respiratory infections. It is crucial to take immediate action to prevent the potential consequences associated with the use of these recalled items.
Recommended Actions:
Nurse Assist, LLC is notifying its distributors and customers by electronic communication and letter and is arranging for replacement of all recalled products. Users are being requested to coordinate the return of product with Nurse Assist, LLC.
If you have the affected saline and sterile water medical products, the FDA strongly advises against using them. It is essential to check your supplies for the brands listed above and the specific product types mentioned earlier. If you find any of the recalled items, please discontinue their use immediately. While Nurse Assist, LLC has not received any reports of adverse events for these products, there is a possibility that the affected product could potentially result in severe or life-threatening adverse events.
The FDA remains committed to working closely with Nurse Assist, LLC to ensure that the public receives prompt notification to discontinue the use of the recalled products. Ongoing monitoring of water-based medical products manufactured by Nurse Assist, LLC is being conducted by the FDA, and any new or additional information will be promptly shared with the public. If you encounter any issues with saline and sterile water medical products from Nurse Assist, LLC, please contact the FDA.
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Kellie Thimmes, aka “Kellie T” is a Compliance Advisor for SafeLink Consulting, Inc. She most recently graduated magna cum laude from Colorado Technical University, with a Bachelor of Science in psychology. Kellie has always had a passion for infection control and prevention and holds multiple certifications including the OSAP/DANB Dental Industry Specialist in Infection Prevention and Control (DISIPC). Most notably, Kellie was the Senior Consultant and Education Specialist for ProEdge Dental Water Labs. Over the years she has helped thousands of dental professionals establish and maintain a safe water protocol.
