Capnostream20 N CYVITAL recall
Capnostream20 N CYVITAL, CS08799
Why was Capnostream20 N CYVITAL recalled?
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
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?
B400002614 B400002628 B400002640 B400002642 B400002645 B400002646 B400002653 B400002658 B400002659 B400002660 B400002750 B400002760 B417135110 B417135186 B417135189 B418135223 B418135272 B418135278 B419135324 B419135329
- Product
- Capnostream20 N CYVITAL, CS08799
- Recalling firm
- Oridion Medical 1987 Ltd.
- Quantity
- 20
- Distribution
- The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)