FDA-Device2021-07-07Class II

Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746

Edwards Lifesciences, LLC
Hazard

There is a potential that the pressure tubing may detach from the blood sampling system

Sold states
US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Affected count
90 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1966-2021

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