FDAFDA · Food and drugs·Recall number Z-0886-2013
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.
Published March 6, 2013 · Recall initiated: February 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Worldwide Distribution - USA Nationwide including Canada.
- Lot
- Catalogue No. 600-290. All lots distributed since 2004.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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