LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
FDA Recall #Z-1344-2025 — Class II — February 6, 2025
Product Description
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
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
1836 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-052911
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated