LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
FDA Recall #Z-1349-2025 — Class II — February 6, 2025
Product Description
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
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
690 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated