FDA-Device2025-09-03Class II
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.
American Contract Systems Inc
Hazard
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.
Sold states
US distribution to states of: IL and LA
Affected count
781 units
Manufactured in
85 Shaffer Park Dr, Tiffin, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2469-2025Don't want to check this manually?
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