Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endosco
FDA device recall Z-0886-2013 · posted 2013-02-26 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KNF
- Quantity affected
- 22,500
- Distribution
- Worldwide Distribution - USA Nationwide including Canada.
- Date initiated
- 2013-02-12
- Date posted
- 2013-02-26
- Date terminated
- 2013-12-24
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JARIT SURGICAL INSTRUMENTS (K932456) | J. Jamner Surgical Instruments, Inc. | 1994-04-21 |