FDA-Device2019-09-11Class II

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

Integra LifeSciences Corp.
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

Sold states
US Nationwide distribution.
Affected count
237 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2019

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