CYSTO , Model No SACY80R
FDA Recall #Z-1346-2025 — Class II — February 6, 2025
Product Description
CYSTO , Model No SACY80R
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
144 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated