FDAClass IISeptember 11, 2019

Integra Jarit GEMINI CLAMP 9 1/4 inch - used in recall

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

Why was Integra Jarit GEMINI CLAMP 9 1/4 inch - used in 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #AA1901

Product
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Recalling firm
Integra LifeSciences Corp.
Quantity
237 units
Distribution
US Nationwide distribution.
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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