Z-2466-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1127 units
Product Description
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.
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 Pattern
US distribution to states of: IL and LA
Code Information
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.