Reported Sep 15, 2021 · Terminated
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series…
Nihon Kohden Orangemed, 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: NIHON KOHDEN ORANGEMED, INC · 1800 E Wilshire Ave · Santa Ana, CA · 92705-4617
Is this the product you have?
- Nihon Kohden NKV-550 Ventilator
- REF
NKV-550-UCE 0344
- UDI(01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support
- Lot codes and dates
- All serial numbers between NKV5502019xxxx - NKV5502112xxxx
- and the following serial numbers below
73 of 73 codes
NKV55019270055NKV55019370098RNKV55019430125RNKV55019470156RNKV55019470160NKV55020130200NKV55020140213RNKV55020140226RNKV55020140229NKV55020150241NKV55020150252NKV55020160268NKV55020160276NKV55020160277NKV55020160292RNKV55020160296NKV55020160297NKV55020160304NKV55020160307NKV55020160308NKV55020160310NKV55020160312NKV55020170317NKV55020170318NKV55020170325NKV55020170335NKV55020170336NKV55020170341NKV55020170342NKV55020170343NKV55020170346NKV55020170347NKV55020170349NKV55020170350NKV55020170352NKV55020170354NKV55020170357NKV55020170360NKV55020180365NKV55020180366NKV55020180369NKV55020180370NKV55020180371NKV55020180372NKV55020180373NKV55020180374NKV55020180375NKV55020180376NKV55020180378NKV55020180379NKV55020180381NKV55020180383NKV55020180384NKV55020180385NKV55020180387NKV55020180391NKV55020180392NKV55020180396NKV55020180397NKV55020180398
- Amount recalled
- 1,999 units
Where it was sold
Why it was recalled
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
This product could cause temporary or reversible health problems — stop using it.
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