AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.

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 EVLP61I: UDI/DI 00191072194831, Kit Lot Numbers: 12-7359211, 12-7077211 , 12-7115211, 12-7162811, 12-7224111, 42-8276811, 42-8200111; 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930, Kit Lot Numbers: 12-7288711, 12-7288711

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