Z-0491-2015Class II

Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector...

Name: Z-0491-2015 Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector...
Creator: Integra LifeSciences Corp.
Published: 2014-09-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-09-29 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One... on 2014-09-29. FDA classified it as Class II and gives the reason as "Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0491-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Posted: 2014-12-01
Terminated: 2015-05-27
Recalling firm: Integra LifeSciences Corporation
Product: 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
Product code: LFL Instrument, Ultrasonic Surgical
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;1134120;1134121;1134122;1134124;1134126;1134128;1134130;1134131;1134132;1134133;1134620;1134621;1134669;1134670;1134671;1134671;1134694;1134695;1140357;1141561;1141562;1141645;1141754;1141563;1141564;1141647;1142352;1142353;1142409; & 1142410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0491-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0491-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01

Product code LFL

K081459UnclassifiedCusa Selector Nxt Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. / cleared 2008-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)