American Contract Systems recall
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK…
Why was American Contract Systems recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK…
- Recalling firm
- American Contract Systems Inc
- Quantity
- 781 units
- Distribution
- US distribution to states of: IL and LA
- Recall date
- September 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)