Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 aspira

U.S. FDA — Device Enforcement · United States · 2014-09-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0491-2015
Date of alert: 2014-09-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Integra LifeSciences Corp.
Product category: device
Product type: Devices

Reported risk: Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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