Edwards Lifesciences, LLC: Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Hazard

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Details from the source

Reason for recall: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Nether Quantity: 6,714 units Lot/code info: AIQS6AZ: UDI: 00690103201109/ Lot # 64891675; AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, 64992113

UPC codes

00690103201109, 00690103200980

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.