Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System

What Is It?

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

How Is ONB Classified?

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System is FDA product code ONB, Class 2, 21 CFR 880.5440.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 904 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 73 recalls under this product code since 2016. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Component design/selection (13), Process control (8) and Equipment maintenance (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.