The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: Medline Kits and Trays

• Distribution Dates: November 1, 2021 to November 10, 2023
• Devices Recalled in the U.S.: 2,675,278
• Date Initiated by Firm: November 15, 2023

Device Use

Medline convenience kits are pre-packaged sets of items that are assembled for specific medical procedures, tasks, or patient needs.

Reason for Recall

Medline Industries is recalling certain kits, trays and packs in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns. These kits contain Nurse Assist saline solution that were recalled due to a lack of sterility. Using non-sterile saline for wound care could lead to severe, life-threatening infections, especially for those who are immunocompromised, undergoing surgery, or critically ill. This is the only saline used in these kits. The recall doesn't affect the integrity of the other kit components.

The use of the affected product may cause serious adverse health consequences, including blood stream infections, urinary tract infections or respiratory infections and in the worst-case scenario sepsis and death.

There have been no reported injuries or deaths associated with this issue.

Who May be Affected

• Health care providers using Medline Industries trays or kits
• People who receive care using Medline Industries trays or kits

What to Do

On November 16, 2023, Medline Industries sent all affected customers an Immediate Action Required Product Recall.

The letter requested customers to:

• Immediately check stock for the affected item number and affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.
• Complete the response form, specifying the quantity of affected product currently in inventory. Even if there is no affected product in inventory, please fill out and submit the response form.
  • Upon receipt of the response form, over-labels to place on affected inventory will be sent, along with instructions for staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
• Notify all relevant parties who may have received this product about this recall communication.

Contact Information

Customers in the U.S. with questions about this recall should contact Medline Industries at 1-866-359-1704.

Additional Resources:

• Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
• Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.