Nihon Kohden NKV-550 Ventilator recall
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to…
Why was Nihon Kohden NKV-550 Ventilator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers between NKV5502019xxxx - NKV5502112xxxx and the following serial numbers below: NKV55019270055, NKV55019370098R, NKV55019430125R, NKV55019470156R, NKV55019470160, NKV55020130200, NKV55020140213R, NKV55020140226R, NKV55020140229, NKV55020150241, NKV55020150252, NKV55020160268, NKV55020160276, NKV55020160277, NKV55020160292R, NKV55020160296, NKV55020160297, NKV55020160304, NKV55020160307, NKV55020160308, NKV55020160310, NKV55020160312, NKV55020170317, NKV55020170318, NKV55020170325, NKV55020170335, NKV55020170336, NKV55020170341, NKV55020170342, NKV55020170343, NKV55020170346, NKV55020170347, NKV55020170349, NKV55020170350, NKV55020170352, NKV55020170354, NKV55020170357, NKV55020170360, NKV55020180365, NKV55020180366, NKV55020180369, NKV55020180370, NKV55020180371, NKV55020180372, NKV55020180373, NKV55020180374, NKV55020180375, NKV55020180376, NKV55020180378, NKV55020180379, NKV55020180381, NKV55020180383, NKV55020180384, NKV55020180385, NKV55020180387, NKV55020180391, NKV55020180392, NKV55020180396, NKV55020180397, NKV55020180398, NKV55020180399, NKV55020180400, NKV55020180401, NKV55020180402, NKV55020180403, NKV55020180405, NKV55020180406, NKV55020180408, NKV55020180409, NKV55020180410, NKV55020180411, NKV55020180412, NKV55020180413
- Product
- Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to…
- Recalling firm
- NIHON KOHDEN ORANGEMED, INC
- Quantity
- 1,999 units
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AZ, CA, NY, MA, VT, LA, DC, PA, FL, UT and OUS (countries) of: Brazil, Japan, Ireland, Poland, Scotland, Germany, Kazakhstan, Spain, Slovenia, Germany/Bulgaria, Russia, India, Palestine, Libya, Jordan Kuwait, Lebanon, Syria, Turkey, South Africa, United Arab Emirates, Mexico, Colombia, Peru, Costa Rica, Barbados, Ecuador, Bahamas, Bolivia, St Kitts & Nevis, St. Martin, Chile, Thailand, Laos, Philippines, Malaysia, Nepal and United Kingdom.
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)