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 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.
FDA has more details in its announcement.