AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, M
Pending LLM rewrite. Source: FDA_DEVICE Z-2469-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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.
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Distributed in 2 states:
- IL
- LA
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