Warmer, Irrigation Solution

What Is FDA Product Code LHC?

Warmer, Irrigation Solution is FDA product code LHC, Class 1, 21 CFR 890.5950.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Packaging (8), Package design/selection (1) and Labeling mix-ups (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.