FDAJuly 14, 2025device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

american contract systemsamericanamerican contract

UPCs

0019107223550300191072193650001910722351380019107223348600191072223197

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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