GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
FDA Recall #Z-1340-2025 — Class II — February 6, 2025
Product Description
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
956 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219510 Lots 70-050850 70-051285 70-051779 70-051779A 70-052186 70-052669 70-053022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated