FDA Notice: Discontinue Use of Recalled Water-Based Medical Products Due to Sterility Concerns

The U.S. Food and Drug Administration (FDA) has issued a warning not to use recalled saline (0.9% sodium chloride) and other water-based medical products manufactured by Nurse Assist, LLC and sold under various brands.

This recall pertains to the following products which may NOT be sterile:

• 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).

These products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol, SteriCare, Trudell, and Vyaire.

The recalled products may be available as individual units or be included as part of a kit. Review the FDA website for a complete list of products included in this recall.

Action Items:

1. Check your supply of saline (0.9% sodium chloride) and sterile water-based medical products (bottles, spray cans, cups, and prefilled syringes) to determine whether you have any of the recalled products in your laboratory
2. Do not use these recalled products in any animal procedures
3. Review the company’s recall notice for detailed instructions on how to return any products you have purchased

Although no adverse events have been associated with these recalled products, please discontinue all use in animals.

Any animal who may have received these products as part of an approved procedure on your animal use protocol should be closely monitored, and all adverse events should be promptly reported to the appropriate U-M Animal Care & Use Program entities.

Questions?

If you are concerned about how your research may be impacted by this recall, or with how the administration of a specific substance could affect the animals on your studies, please contact your ULAM Faculty Veterinarian.

If you don’t know your veterinarian, send an email to the ULAM Business Office at ulam-questions@umich.edu and your question will be routed appropriately.