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                Recalls, Market Withdrawals, & Safety Alerts

Recalls, Market Withdrawals, & Safety Alerts

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          Recalls, Market Withdrawals, & Safety Alerts
          Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure KitRecalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit

  
    
        When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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  Company Announcement Date:
             January 22, 2024

                          FDA Publish Date: 
               January 23, 2024
                                    Product Type: 
              Medical Devices
                          Reason for Announcement:
              Recall Reason Description
              Product cannot be verified as having the required sterility assurance level

            Company Name: 
              Aligned Medical Solutions

            Brand Name:
              Brand Name(s)
          Aligned Medical Solutions

            Product Description:
              Product Description
          Convenience kits containing saline   
Company Announcement



On December 22, 2023, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of Nurse Assist Sterile Saline which is piggybacked [attached to the outside of the kit in a separate pouch] to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit.

Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit.

Recalled products include:

Brand
			Aligned Medical SolutionsKit Name
			Product Code
			DI Number
			LotLocal Lower
			Extremity Pack I
			AMS10833
			B098AMS108330
			173179, 176590, 174338, 175529, 176217, 178271,
			178489, 180907, 183355, 181439, 183674, 184398,
			185064, 188137, 189007, 189640, 189641, 189642,
			191067, 192551, 194252, 196380, 197727, 198046,
			197727, 198373, 199297In House Ocular
			Pack
			AMS12947
			B098AMS129470
			192389, 194805In House Ocular
			Pack
			AMS12947A
			B098AMS12947A0
			192436, 192774, 196582Closure Kit
			AMS13043
			B098AMS130430
			178114, 187325, 191102, 195504, 196502, 197864

These convenience kits contain the recalled Nurse Assist Sterile Saline, Brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle, which has been recalled because the Nurse Assist product cannot be verified as having the required sterility assurance level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation 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

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening 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.

Aligned Medical Solutions distributed these kits nationwide. Recalled Product(s) were manufactured from 06/02/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023.

No injuries have been reported to date.

Customers who have affected product[s] should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement product if needed at 406.259.6387. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, quarantined, and disposed of pursuant to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s].

Customers with questions may contact the company via telephone at 1-800 -637-7056 between the hours of 8:00 am and 5:00 pm (Mountain Time). Customers may also contact the company via e-mail at fieldcorrectiveaction@alignedmedicalsolutions.com.

Please contact your McKesson Sales Rep or Vicki Davis at vdavis@alignedmedical.com / 406-259-6387 for replacement product.

Aligned Medical Solutions has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report **Online:** www.fda.gov/medwatch/report.htm
	**Regular Mail or Fax:** Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178





Company Contact Information
  
  
    Consumers:       

                 Aligned Medical Solutions
        
                 1-800 -637-7056
        
                 fieldcorrectiveaction@alignedmedicalsolutions.com



  Product Photos

            “Local Lower Extremity Pack Label product code AMS10833”
    “In house Ocular Pack label product code AMS12947”
    “In house Ocular Pack label product code AMS12947A”
    “Closure Kit label product code AMS13043”

                                                                                  Content current as of:
      01/23/2024
               
             
Regulated Product(s)
		 Medical Devices   
        
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