FDAFebruary 6, 2025device

CYSTO PACK , Model N. HKCY31A

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

The hazard

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

What to do

FDA enforcement status: Ongoing

Brands named

american contract systemsamericanamerican contract

UPCs

00191072059093

Recall history

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

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