REGULATORY UPDATE: FDA Releases Advisory Regarding Certain Saline and Sterile Water Medical Products

The Food and Drug Administration published an advisory on Friday warning facilities that manufacture human cells, tissues and cellular and tissue-based products (HCT/Ps) that certain saline and water-based medical products produced by Nurse Assist, LLC may be contaminated with bacteria and, therefore, could affect patient safety.

FDA reminded facilities that Nurse Assist, LLC issued a recall in November for the following products:

• 0.9% Sodium Chloride Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 3.1oz spray can, 7.1oz spray can, 3 mL syringes, 5 mL syringes, and 10mL syringes)
• Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10 mL syringes, and 30 mL syringes)

FDA reminded facilities that Nurse Assist, LLC products are sold under various brands, including Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell and Vyaire.

FDA recommended staff at facilities check their supply of saline and sterile water medical products to determine whether there are any recalled products in their inventory. “Do not use these recalled products and follow the recommendations in the company’s recall announcement,” FDA said in its communication. “Be aware that these recalled products may be available as individual units or may be included as part of a kit."

FDA said it was releasing this advisory now in response to myriad questions from facilities regarding the particulars of the recall.