American Contract Systems Inc — AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Num
⚠️ 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.
Is this relevant to me?
- Geography
- US, IL, LA
- Source agency
- FDA
- Category
- Health
- Published
- July 14, 2025
US distribution to states of: IL and LA
What's affected?
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
- Lot code
- 70-051710
Additional details
1) Model/Item Number LLBN11C: UDI/DI 00191072233530, Kit Lot Numbers: 70-051710, 70-052354; 2) Model/Item Number LLLD19I: UDI/DI 00191072233493, Kit Lot Numbers: 70-051324, 70-051967, 70-053006, 70-053303, 70-053710.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 781 units.
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