FDA recall Z-1964-2021

Edwards Lifesciences, LLC · Class II · device

Product

Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-05-26
Report date
2021-07-07
Termination date
2023-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1964-2021