Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding…

Recall date
August 7, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2435-2019
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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