FDA Device recall Z-0491-2015
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical A…
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical A… by Integra Lifesciences, citing some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0491-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-29 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers: 130849;1132912;1132913;1132914;1133101;1133102;1133103;1133104;1133105;1133495;1134005;1134006;1134007;113…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2015%22
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