January 31, 2024

FDA updates safety recall of certain saline, sterile water medical products

Editor's Note

The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse Assist, including saline and sterile water used for medical irrigation or flushing, sold under multiple brands.

Calling attention to how these products might not be sterile and potentially contaminated, posing serious infection risks, especially to vulnerable individuals like the elderly, critically ill, or those with weak immune systems, the FDA is warning against the use of these recalled products and is investigating reports of adverse events linked to them.

Some highlights of the recall notice are:

  • Nurse Assist's recall includes products like 0.9% Sodium Chloride Irrigation and Sterile Water for Irrigation in various packaging forms.
  • The affected products were sold under several brands and might be part of medical kits.
  • Recommendations for consumers, healthcare providers, and facilities include checking supplies for and not using the recalled products, and reporting any problems to the FDA.
  • The FDA is actively working with Nurse Assist to manage the recall and will continue to update on any new information.

A table listing the affected products with pertinent information, including the Unique Device Identifier (UDI), is available on the FDA’s website. Note that the expiration date for all products is September 18, 2025, except for the ones under 1030A, which have an expiration date of September 18, 2028.


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