Reported Dec 10, 2014 · Terminated
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers
13084911329121132913113291411331011133102113310311331041133105113349511340051134006113400711341201134121113412211341241134126113412811341301134131113413211341331134620113462111346691134670113467111346711134694113469511403571141561114156211416451141754114156311415641141647114235211423531142409& 1142410
- Lot Numbers
- Amount recalled
- 6,358 tubing kits
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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