LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
FDA Recall #Z-1337-2025 — Class II — February 6, 2025
Product Description
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-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
630 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated