BORN ON ARRIVAL KIT , Model No LLBN11B
FDA Recall #Z-1341-2025 — Class II — February 6, 2025
Product Description
BORN ON ARRIVAL KIT , Model No LLBN11B
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
54 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072219558 Lots 891241 70-051710 70-052354
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated