Recall Z-0491-2015 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
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 t
| Date | Dec 1, 2014 (initiated Sep 29, 2014) |
| Status | Terminated |
| Reason | Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner. |
| Root cause | Device Design |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM Integra Radionics, Inc., Aug 13, 2008 |