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

Recall Z-0788-2014 — TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (

U.S. FDA — Device Enforcement · United States · 2013-10-11 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0788-2014
Date of alert: 2013-10-11
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Codman & Shurtleff, Inc.
Product category: device
Product type: Devices

Reported risk: Incorrect instructions for use (IFU).

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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