Reported Aug 15, 2018 · Terminated
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in…
Datex-Ohmeda, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datex-Ohmeda, Inc. · 3030 Ohmeda Dr · Madison, WI · 53718-6704
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number1506-8600-000
- Serial NumbersModel Number 1505-5604-000
386 of 386 codes
CBRX00981CBRX00984CBRX00985CBRX00988CBRX00990CBRX00438CBRX00368CBRX00369CBRX01033CBRX01043CBRX01044CBRX01048CBRX01052CBRX00201CBRX00208CBRX00209CBRX00210CBRX00212CBRX00213CBRX00214CBRX00215CBRX00216CBRX00217CBRX00749CBRX00750CBRX01124CBRX01131CBRX01136CBRX01160CBRX01162CBRX01163CBRX01164CBRX01165CBRX01166CBRX01169CBRX01017CBRX01042CBRX01068CBRX01069CBRX01070CBRX01071CBRX01083CBRX01090CBRX01091CBRX01097CBRX01106CBRX01107CBRX01112CBRX01115CBRX01116CBRX01117CBRX01118CBRX01122CBRX01125CBRX01126CBRX01127CBRX01128CBRX01132CBRX01133CBRX01134
- Serial NumbersModel Number 2080496-010
5473124-15475131-15473274-15471291-25469052-25472210-15473192-15473943-35466481-15466360-25472842-15470666-15473198-15466642-15470881-15461218-15468985-15471539-1
- Serial Numbers:
5473274-15471291-15469462-15469869-15471316-15473943-15473943-25467910-15466360-15468261-15468261-25472270-15467664-1
- Amount recalled
- 417 units
Where it was sold
Why it was recalled
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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