Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

On November 6, 2023, 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. 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.

To date, Nurse Assist, LLC has not received any reports of adverse events for these products.

The product was distributed in the United States and Canada. 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:

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

Detailed product information is as follows:

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.

Consumers with questions may contact the company via telephone at 800-649-6800 Monday through Friday between the hours of 8am and 430pm (cst). Consumers may also contact the company via e-mail at [email protected].

Nurse Assist, LLC 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