FDAFDA · Food and drugs·Recall number Z-2468-2025
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.
Published September 3, 2025 · Recall initiated: July 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems Inc
- Distributor
- US distribution to states of: IL and LA
- Lot
- 1) MODEL/ITEM NUMBER UICR10W: UDI/DI 00191072207241, Kit Lot Numbers: 42-7828711, 42-7980711, 42-8063211, 42-8124011; 2) MODEL/ITEM NUMBER UISH55V: UDI/DI 00191072235442, Kit Lot Numbers: 42-7799111, 42-7985211, 42-8065111, 42-8140711.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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