Absorber, Carbon-Dioxide

What Is FDA Product Code BSF?

Absorber, Carbon-Dioxide is FDA product code BSF, Class 1, 21 CFR 868.5310.

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 Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2003. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Device Design (2) and Vendor change control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.