LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
FDA Recall #Z-1352-2025 — Class II — February 6, 2025
Product Description
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
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
237 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072167491 00191072218698 Lots 971241 947241 926241 894241 70-051029 70-051995 70-052417 70-052771
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated