Recall Z-2738-2018— Datex-Ohmeda, Inc.

Name: FDA recall Z-2738-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Class II · Terminated

Class II FDA medical device recall by Datex-Ohmeda, Inc., initiated 2018-06-28, terminated 2019-02-22. It names one FDA 510(k) clearance: K142679. 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: The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable..

Recalling firm: Datex-Ohmeda, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-28
Terminated: 2019-02-22
Firm location: Madison, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K142679 — CARESCAPE R860Datex-Ohmeda, Inc.·cleared 2015-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.