Home / Recalls / Edwards Lifesciences, LLC / Z-0411-2024

Z-0411-2024 Class II Ongoing

Recalled by Edwards Lifesciences, LLC — Irvine, CA

Recall Details

Product Type
Devices
Report Date
December 6, 2023
Initiation Date
October 4, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1417 units

Product Description

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Reason for Recall

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

Distribution Pattern

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 Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

Code Information

MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926

Other recalls by Edwards Lifesciences, LLC

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  • Z-2083-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2080-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-2084-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2082-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-0412-2024 Class II — FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx on (October 4, 2023)
  • Z-0413-2024 Class II — TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (October 4, 2023)
  • Z-0410-2024 Class II — Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. (October 4, 2023)
  • Z-0409-2024 Class II — Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, (October 4, 2023)