PlainRecalls
FDA Devices Moderate Class II Terminated

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

Reported: March 6, 2013 Initiated: February 12, 2013 #Z-0886-2013

Product Description

Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.

Reason for Recall

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.

Details

Units Affected
22,500
Distribution
Worldwide Distribution - USA Nationwide including Canada.
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.. Recalled by Integra LifeSciences Corp.. Units affected: 22,500.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0886-2013.