FDA-Device2025-09-03Class II
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
American Contract Systems Inc
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.
Sold states
US distribution to states of: IL and LA
Affected count
204 units
Manufactured in
85 Shaffer Park Dr, Tiffin, OH, United States
Products
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2468-2025Don't want to check this manually?
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