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
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