American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN1…

Recall date

July 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2469-2025

FDA classification

Class II

Brand / firm

American Contract Systems Inc

Sold / distributed

US distribution to states of: IL and LA

Why it was recalled

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.