Datex-Ohmeda, Inc. recalls The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neon…

Recall date

June 28, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2738-2018

FDA classification

Class II

Brand / firm

Datex-Ohmeda, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pak…

Why it was recalled

The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.