FDA recalls some saline, sterile water brands for possible contamination
- The FDA is warning consumers, healthcare providers to check their products
- The recall impacts dozens of saline, sterile water items
- Non-sterile water-based products could cause serious infections
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(NewsNation) — The U.S. Food and Drug Administration is warning consumers, healthcare providers and healthcare facilities that some brands of saline and sterile water medical products may not be sterile.
The FDA’s recall impacts the following products, manufactured by Nurse Assist and sold under several brands:
- 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 are sold under brands including: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor and more.
The impacted products were distributed in the U.S. and Canada from Nov. 1, 2021, to Sept. 18, 2023, and have expiration dates between Nov. 1, 2023 to Sept. 18, 2028.
The FDA recommends consumers check their saline and sterile water products and avoid use of the recalled items.
“Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections, including bloodstream, urinary tract, open wound/soft tissue, and respiratory infections,” the FDA announced.
