Home / Recalls / LeMaitre Vascular, Inc. / Z-0473-2019

Z-0473-2019 Class II Terminated

Recalled by LeMaitre Vascular, Inc. — Burlington, MA

Recall Details

Product Type
Devices
Report Date
November 28, 2018
Initiation Date
October 1, 2018
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
46 units

Product Description

LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

Reason for Recall

Pouches from this lot are not sealed compromising the sterility

Distribution Pattern

FL Foreign: Austalia, Korea

Code Information

LOT# PFP1055 Expiration Date: 2020-03-28

Other recalls by LeMaitre Vascular, Inc.

  • Z-0289-2026 Class II — Artegraft¿ Collagen Vascular Graft; REF: AG1015; (September 25, 2025)
  • Z-0034-2026 Class II — Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) A (September 2, 2025)
  • Z-0072-2026 Class II — Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, (August 25, 2025)
  • Z-1751-2025 Class II — Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, (April 11, 2025)
  • Z-1750-2025 Class II — TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38 (April 11, 2025)
  • Z-1752-2025 Class II — Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09. (April 11, 2025)
  • Z-1824-2024 Class II — Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts (April 17, 2024)
  • Z-2468-2023 Class II — The Chevalier Valvulotome is a device used to disrupt the valves of veins which (July 13, 2023)
  • Z-0228-2023 Class II — TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and (September 30, 2022)
  • Z-1529-2021 Class II — LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Produ (April 6, 2021)