FDAMay 6, 2024device

American Contract Systems Gyn Laparoscopy convenience kit

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

The hazard

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

What to do

FDA enforcement status: Ongoing

Brands named

american contract systemsamericanamerican contract

UPCs

0019107220201700191072188458

Recall history

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

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