Catheter, Peritoneal

How Is GBW Classified?

Catheter, Peritoneal is FDA product code GBW, Class 1, 21 CFR 878.4200.

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 15 recalls under this product code since 2004. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (2), Packaging process control (1) and Labeling False and Misleading (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.