Home / Recalls / Edwards Lifesciences, LLC / Z-2007-2020

Z-2007-2020 Class II Terminated

Recalled by Edwards Lifesciences, LLC — Irvine, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2020
Initiation Date
March 27, 2020
Termination Date
April 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
597 units

Product Description

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

Reason for Recall

Sterile catheter kit packaging compromised.

Distribution Pattern

US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

Code Information

Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932

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)