An insect is the cause of a voluntary recall of surgical irrigation fluid by Baxter International. The single lot, number G120162, is of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution, and was distributed between Nov. 12, 2015 and Jan. 11, 2016. Baxter told its customers to return the product.
The species of the ‘foreign matter’, as the U.S. Food and Drug Administration (FDA) calls the bug, has not been identified, but using the fluid can reportedly result in:
- Inflammatory reaction
- Foreign body reaction
- Life threatening infections
For more information, visit the FDA’s website HERE.
Filed Under: Industry regulations