AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;

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 CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number HNLC80J: UDI/DI 00191072193650, Kit Lot Numbers: 42-8044511, 42-8118911, 42-7977011, 42-7803211; 3) Model/Item Number JKLC55H: UDI/DI 00191072235138, Kit Lot Numbers: 42-7814311; 4) Model/Item Number LLLA21K: UDI/DI 00191072233486, Kit Lot Numbers: 70-052582, 70-053048, 70-051564, 70-051373, 70-051163, 70-053446, 70-053776; 5) Model/Item Number MPGL15G: UDI/DI 00191072223197, Kit Lot Numbers: 5436916, 5436615

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