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Terminated

Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approval

FDA Recall Z-0491-2015 · Posted 2014-12-01

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeLFL
Date Initiated2014-09-29
Date Terminated2015-05-27
Product Quantity6,358 tubing kits

Reason for Recall

Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.

Firm Action

Integra sent an 'Urgent- Medical Device Correction' letters/acknowledgement forms dated 9/29/2014 by traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for the affected product, complete the attached form. Complete the other information on the form and return the form by email or fax. Customers with questions should contact Customer Service at 1-855-532-1723.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand, Turkey, and Wales.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMIntegra Radionics, Inc. · 2008-08-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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