Recalls / —
—#115922
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.
- FDA product code
- KNF — Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K932456
- Affected lot / code info
- Catalogue No. 600-290. All lots distributed since 2004.
Why it was 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.
Root cause (FDA determination)
Other
Action the firm took
Integra sent an Urgent Medical Device Correction Field Safety Notice letter dated February 12, 2013 and a copy of the Instructions for Use addendum to all affected customers. The letter identified the product, nature of the issue and actions to be taken. Customers were requested to examine their inventory for the affected product and include a copy of the addendum to that inventory. Customers were instructed to complete and return the Acknowledgement Return Form and provide a copy of the IFU addendum to any of their customers that had purchased the Jarit(R0 Monopolar Cable. For questions call Integra Surgical Customer Service at 800-431-1123.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Worldwide Distribution - USA Nationwide including Canada.
Timeline
- Recall initiated
- 2013-02-12
- Posted by FDA
- 2013-02-26
- Terminated
- 2013-12-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #115922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.