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Datex-Ohmeda, Inc. recalls The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neona
Recalled August 15, 2018 · FDA recall Z-2738-2018 · Datex-Ohmeda
Hazard
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. · FDA Class II
Units
417 units
Sold at
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.
Description
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
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.
Manufacturer(s)
Datex-Ohmeda, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →