Home / Recalls / Edwards Lifesciences, LLC / Z-1964-2021

Z-1964-2021 Class II Terminated

Recalled by Edwards Lifesciences, LLC — Irvine, CA

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
May 26, 2021
Termination Date
December 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
990 units

Product Description

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 Pattern

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

Code Information

Lot # 63438489

Other recalls by Edwards Lifesciences, LLC

  • Z-2082-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (May 14, 2025)
  • Z-2081-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-2083-2025 Class I — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N (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-2085-2025 Class I — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Nu (May 14, 2025)
  • Z-2080-2025 Class I — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula (May 14, 2025)
  • Z-0410-2024 Class II — Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. (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-0409-2024 Class II — Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, (October 4, 2023)
  • Z-0414-2024 Class II — TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (October 4, 2023)