LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
FDA Recall #Z-1331-2025 — Class II — February 6, 2025
Product Description
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
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
303 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated