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.

Reason: 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.

Code information: 1) Model/Item Number LLBN11C: UDI/DI 00191072233530, Kit Lot Numbers: 70-051710, 70-052354; 2) Model/Item Number LLLD19I: UDI/DI 00191072233493, Kit Lot Numbers: 70-051324, 70-051967, 70-053006, 70-053303, 70-053710.

Distribution pattern: US distribution to states of: IL and LA