Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist

Feb. 27, 2024
The FDA is recalling more saline and sterile water products made by the company after receiving reports of adverse events

According to a Feb. 13 update, in direct response to the Nurse Assist, LLC recall on November 6, 2023, distributors of Nurse Assist water-based medical products and manufacturers of kits and trays that contain Nurse Assist recalled products are initiating voluntary recalls.

We reported on Nov. 7, 2023, that 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.

The list of additional recalls and affected products are described in the updated recall information.

The FDA is receiving reports of adverse events associated with use of Nurse Assist products and is further evaluating this information.

FDA has the updated information.