Consumers, healthcare providers and healthcare facilities are advised against use of certain recalled saline (0.9% sodium chloride) and sterile water medical products, sold under various brands, which have been recalled by the manufacturer, Nurse Assist, LLC, reports the FDA.
Used for irrigation, as in the flushing of wounds and medical tubing, as well as for other medical purposes, water-based medical products are partly composed of sterile saline (0.9% sodium chloride).
The recall was first announced by Nurse Assist, LLC on November 6, 2023, due to concerns about the sterility of the following water-based medical 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, 3mL syringes, 5mL syringes, and 10mL syringes);
- Sterile Water for Irrigation USP (100 mL bottles, 250 mL bottles, 500 mL bottles, 1000 mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes).
Made available for purchase as individual units and as part of a kit, the recalled products can be found under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire.
Officials warn that using non-sterile water-based medical products, or those potentially contaminated with bacteria, may result in significant or life-threatening infections. These infections could impact the bloodstream, the urinary tract, open wounds and soft tissue, as well as the respiratory system.
Those especially at risk to infection posed by the non-sterile products include elderly and critically ill patients, those with weak immune systems–such as neonates, pregnant women, cancer patients–and individuals with chronic diseases. Other patients who are exposed to the potentially-contaminated products also run the risk of developing infections.
While the FDA has not been notified of related adverse events to date, the agency continues to collaborate with Nurse Assist, LLC to notify consumers about the recall and keep the public informed of new information. The FDA also continues to monitor reports detailing issues in Nurse Assist, LLC-manufactured water-based medical products.
A complete list of affected products, along with their Unique Device Identifier (UDI), can be referenced in the FDA announcement. All recalled products carry the following expiration dates:
- November 1, 2023 – September 18, 2025 (all products, except for 1030A)
- November 1, 2023 – September 18, 2028 (part number 1030A)
Consumers who experienced adverse events or issues related to the recalled products are urged to report them to the FDA’s MedWatch program. Those employed at facilities under the FDA’s user facility reporting requirements should adhere to their facility’s established reporting protocols. Further questions can be addressed to the Division of Industry and Consumer Education (DICE) via email at DICE@FDA.HHS.GOV, or by calling 800-638-2041 or 301-796-7100.
TruLaw’s seasoned attorneys are equipped to help families like yours pursue the compensation they deserve after an adverse health outcome caused by a contaminated medical drug. If you or a loved one has developed a bacterial infection that can be traced to a water-based medical product, we would like to support you in the legal process. Connect with us online or try out our free Instant Case Evaluation ℠ to get started.