FDAAugust 7, 2019device

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

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

The hazard

A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in premature need for replacement and/or breakage of the instrument

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

Recall history

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

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