Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          FDA Roundup: November 7, 2023Press Announcements FDA News Release
  FDA Roundup: November 7, 2023

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  November 07, 2023
 

  
      
       

  Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Monday, the FDA issued a Safety Communication 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. On November 6, 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.
	On Monday, the FDA announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns. ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers. Published by the American National Standards Institute, Inc, and the Association for the Advancement of Medical Instrumentation, it aligns with existing international safety risk management standards and quality systems expectations. It also provides direction to sponsors on how to consider and address cybersecurity risks in device design and development. We encourage the use of this new standard to enhance quality and support product performance. Recognized Consensus Standards: Medical Devices
	On Friday, the FDA published the “Catching Up with Califf:” “Thoughts on Singapore, and FDA’s Ongoing Work to Improve Public Health,” by: Robert M. Califf, M.D., Commissioner of Food and Drugs. As part of the recent trip to India, Dr. Califf and the FDA team also stopped by Singapore for a few days. Dr. Califf reflects on the trip to Singapore, shares thoughts about the FDA’s global presence and strengthening ties with an FDA strategic partner, touches on opportunities and challenges in applying technological innovation around the world and adds some additional reflections about this part of the world.
	On Friday, the FDA issued an updated advisory for the investigation of elevated lead levels linked to certain apple cinnamon puree pouches. Exposure to lead can be particularly harmful to children. Consumers should not eat, sell, or serve recalled WanaBana, Schnucks, and Weis brand apple cinnamon pouches and should discard them. The FDA has received additional reports of illnesses and is working to evaluate those complaints. The FDA’s investigation is ongoing to determine the source of lead contamination and whether additional products are linked to illnesses. The FDA will update this advisory as information becomes available.
	On Friday, the FDA cleared for marketing the Control-IQ Technology, a software-only device intended for use with compatible integrated continuous glucose monitors (iCGMs) and alternate controller-enabled insulin pumps (ACE pumps) for the management of type 1 diabetes in persons two (2) years of age and older. Control-IQ Technology—along with its compatible iCGMs and ACE pumps—can automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold (for example, based on carbohydrate intake, exercise, and sleep schedule). Control-IQ Technology is for prescription-use only. This is the latest example of the FDA’s ongoing commitment to help advance the development and expansion of products that can improve the management of type 1 diabetes, especially for pediatric patients. In addition to the clinical studies that the FDA reviewed to support this clearance, Tandem Diabetes Care, Inc., the manufacturer of Control-IQ Technology, will also conduct a post-market surveillance study with subjects ages 2-5 years old to collect additional information on device performance during real-world use.FDA reviewed to support this clearance, Tandem Diabetes Care, Inc., the manufacturer of Control-IQ Technology, will also conduct a post-market surveillance study with subjects ages 2-5 years old to collect additional information on device performance during real-world use.Related Information
  
  Related Information
              FDA Newsroom

###
  Boilerplate
      The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Inquiries
  
    
        
         Media:
                 
      
                            FDA Office of Media Affairs
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      11/07/2023
               
               
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical Devices   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop