Z-1349-2025 Class II Ongoing

Recalled by American Contract Systems Inc — Tiffin, OH

Recall Details

Product Type
Devices
Report Date
March 26, 2025
Initiation Date
February 6, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
690 kits

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.

Distribution Pattern

US Nationwide distribution in the state of OH.

Code Information

UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662