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Integra LifeSciences Corp. recalls Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid en
Recalled March 6, 2013 · FDA recall Z-0886-2013 · Integra LifeSciences
Hazard
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. · FDA Class II
Units
22,500
Sold at
Worldwide Distribution - USA Nationwide including Canada.
Description
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.
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 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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →