Home / Recalls / Cook Medical Incorporated / Z-1832-2024

Z-1832-2024 Class II Ongoing

Recalled by Cook Medical Incorporated — Bloomington, IN

FDA device recall Z-1832-2024 was initiated by Cook Medical Incorporated on April 1, 2024 and is designated Class II. Reason for recall: Devices may contain elevated levels of bacterial endotoxin. The recall status is ongoing. Affected quantity: 1 Unit OUS.

Recall Details

Product Type
Devices
Report Date
May 22, 2024
Initiation Date
April 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 Unit OUS

Product Description

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Reason for Recall

Devices may contain elevated levels of bacterial endotoxin.

Distribution Pattern

International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

Code Information

Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.

Other recalls by Cook Medical Incorporated

  • Z-0043-2026 Class I — Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Pa (September 18, 2025)
  • Z-1833-2024 Class II — EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 (April 1, 2024)
  • Z-0875-2022 Class III — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN (February 14, 2022)
  • Z-0876-2022 Class III — Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM- (February 14, 2022)
  • Z-1024-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Nu (February 25, 2019)
  • Z-1022-2019 Class III — Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IG (February 25, 2019)
  • Z-1025-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Nu (February 25, 2019)
  • Z-1023-2019 Class III — Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catal (February 25, 2019)
  • Z-1021-2019 Class III — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IG (February 25, 2019)
  • Z-1026-2019 Class III — Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (February 25, 2019)

FDA data resources