Accessory Equipment, Cardiopulmonary Bypass

What Is FDA Product Code KRI?

Accessory Equipment, Cardiopulmonary Bypass is FDA product code KRI, Class 1, 21 CFR 870.4200.

How Does It Reach the US Market?

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 8 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Incorrect or no expiration date (3), Device Design (2) and Labeling design (1).

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