LABOR & DELIVERY PACK, Model Nos LLLD19H
FDA Recall #Z-1338-2025 — Class II — February 6, 2025
Product Description
LABOR & DELIVERY PACK, Model Nos LLLD19H
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
725 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219213 Lots 885241 70-051324 70-051967 70-052455 70-053006
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated