American Contract Systems Inc: AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.

Hazard

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.

Details from the source

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: 50 units Lot/code info: 1) MODEL/ITEM NUMBER GRRB10E: UDI/DI 00191072236371, Kit Lot Numbers: 42-8157011, 42-8126811; 2) MODEL/ITEM NUMBER SPVH62P: UDI/DI 00191072238771, Kit Lot Numbers: 12-7322911, 12-7384911.

UPC codes

00191072236371, 00191072238771

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.