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.
Reason for recall: 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. Distribution: US distribution to states of: IL and LA Quantity: 1127 units Lot/code info: 1) Model/Item Number ASCY24A: UDI/DI 00191072201621, Kit Lot Numbers: 12-7370111, 12-7388611, 12-7388611, 12-7139611, 12-7191911, 12-7231611, 12-7263911; 2) Model/Item Number BUCY78E: UDI/DI 00191072235350, Kit Lot Numbers: 42-7962811; 3) Model/Item Number LMCP22T: UDI/DI 00191072235510, Kit Lot Numbers: 42-8027411, 42-8106111, 42-7885511, 42-7823511; 4) Model/Item Number LMTU31T: UDI/DI 00191072235527, Kit Lot Numbers: 42-7987311, 42-8059311, 42-8112211, 42-7832311, 42-7845011, 42-7914911; 5) Model/Item Number SACY80S: UDI/DI 00191072233370, Kit Lot Numbers: 70-052954, 70-052248, 70-51139, 70-053309, 70-053805; 6) Model/Item Number SPUR64F: UDI/DI 00191072238764, Kit Lot Numbers: 12-7394711, 12-7328411, 12-7096811, 12-7168211.
00191072201621, 00191072235350, 00191072235510, 00191072235527, 00191072233370, 00191072238764
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.