FDA-Device2021-07-07Class II
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
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
460 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1959-2021Don't want to check this manually?
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