Recall Z-0886-2013 ยท KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Integra LifeSciences Corp.
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.
| Date | Feb 26, 2013 (initiated Feb 12, 2013) |
| Status | Terminated |
| Reason | 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 | Other |
| 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 |
| Quantity | 22,500 |
| Distribution | Worldwide Distribution - USA Nationwide including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932456 | JARIT SURGICAL INSTRUMENTS J. Jamner Surgical Instruments, Inc., Apr 21, 1994 |