FDAClass IIMarch 6, 2013

Integra(R) Jarit(R) Monopolar Cable recall

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping…

Why was Integra(R) Jarit(R) Monopolar Cable recalled?

Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.

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?

Catalogue No. 600-290. All lots distributed since 2004.

Product
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping…
Recalling firm
Integra LifeSciences Corp.
Quantity
22,500
Distribution
Worldwide Distribution - USA Nationwide including Canada.
Recall date
March 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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