Integra Selector Kit Sterile single use device A bi-lumen — Class II medical device recall Z-0491-2015
Terminated recall by Integra LifeSciences Corp., reported 2014-12-10, distributed nationwide. Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Se
| Recall number | Z-0491-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-09-29 |
| Classified | 2014-12-01 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, CA, DE, DZ, ES, GB, GR, HU, ID, IL, IT, JP, MX, PT, SE, TH, TR |
| Quantity | 6,358 tubing |
| Reason classes | packaging |
| Lot numbers | 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, 1134694, 1134695, 1140357, 1141561, 1141562, 1141563, 1141564, 1141645, 1141647, 1141754, 1142352, 1142353, 1142409 and 2 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0491-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.