C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
FDA Recall #Z-1336-2025 — Class II — February 6, 2025
Product Description
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
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
252 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219107 Lots 70-051011 70-051709 70-052452 70-052952
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated