PlainRecalls
FDA Devices Moderate Class II 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 disinte

Reported: December 10, 2014 Initiated: September 29, 2014 #Z-0491-2015

Product Description

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

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.

Details

Units Affected
6,358 tubing kits
Distribution
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.
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Integra LifeSciences Corp.. Units affected: 6,358 tubing kits.
Why was this product recalled?
Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0491-2015.