Safety Report: Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP - due to Lack of sterility assurance, USA

United States

Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. The product was distributed in the United States and Canada. To date, Nurse Assist, LLC has not received any reports of adverse events for these products.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

Recalled Product was distributed from November 1, 2021 to September 18, 2023. Recalled products include the following products, these products may be packaged inside kits:

Product: 0.9% Sodium Chloride Irrigation USP, Size: 100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes.

Product: Sterile Water for Irrigation USP, Size: 100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes

Expiration dates range from November 1, 2023 to September 18, 2025 for all part numbers, with the exception of part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N), which has an expiration date range from November 1, 2023 to September 18, 2028.

You can find detailed product information on the link below.

Recalled products may be repackaged into medical device convenience kits.

The potential for a compromised sterile barrier was identified during routine product testing. Further investigations prompted a widening of product scope out of an abundance of caution.

Consumers who have these products should stop using them and contact their distributor or Nurse Assist, LLC for return authorization.

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.

Company name: Nurse Assist, LLC
Brand name: Multiple brand names
Product recalled: 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP
Reason of the recall: Lack of sterility assurance
FDA Recall date: November 06, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nurse-assist-llc-issues-recall-09-sodium-chloride-irrigation-usp-and-sterile-water-irrigation-usp