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 Recall Z-0886-2013 · Posted 2013-02-26
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeKNF
Date Initiated2013-02-12
Date Terminated2013-12-24
Product Quantity22,500
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - USA Nationwide including Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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