FDA recall Z-1959-2021

Edwards Lifesciences, LLC · Class II · device

Product

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

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-1959-2021