FDA: Class I recall of Maquet FLOW-I Anesthesia Systems

Editor's Note

The Food and Drug Administration on July 1 issued a Class I recall, the most serious, of FLOW-I Anesthesia Systems by Maquet.

Maquet has received 10 reports of patient cassettes (ie, the center of gas flow in the system) coming loose. The cassette locking device may accidentally release the cassette from its mount when users perform a change of system, which may cause anesthesia gas to leak and prevent the ventilator from providing breathing support.

A total 1641 units are affected by the recall, covering products with article numbers 66 77 200, 66 77 300, and 66 77 400. The devices being recalled were manufactured and distributed between May 5, 2014 and July 7, 2015.

ISSUE: FDA is providing notification of a Class 1 recall of FLOW-i Anesthesia Systemsby Maquet. The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose.