American Contract Systems recall
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;
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 CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number HNLC80J: UDI/DI 00191072193650, Kit Lot Numbers: 42-8044511, 42-8118911, 42-7977011, 42-7803211; 3) Model/Item Number JKLC55H: UDI/DI 00191072235138, Kit Lot Numbers: 42-7814311; 4) Model/Item Number LLLA21K: UDI/DI 00191072233486, Kit Lot Numbers: 70-052582, 70-053048, 70-051564, 70-051373, 70-051163, 70-053446, 70-053776; 5) Model/Item Number MPGL15G: UDI/DI 00191072223197, Kit Lot Numbers: 5436916, 5436615
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;
- Recalling firm
- American Contract Systems Inc
- Quantity
- 1233 units
- Distribution
- US distribution to states of: IL and LA
- Recall date
- September 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)