Class II
Medical Device Recall: 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.
American Contract Systems Inc · July 14, 2025
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
States Affected
IL, LA
Quantity Affected
50 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2471-2025
Status: ongoing
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