FDA recall Z-2738-2018

Datex-Ohmeda, Inc. · Class II · device

Product

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.

Reason for recall

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

Distribution

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, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, and Vietnam.

Key facts

Status
Terminated
Initiation date
2018-06-28
Report date
2018-08-15
Termination date
2019-02-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2018