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Terminated

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 (AVMs) when pre-surgical devascularization is desired.

FDA Recall Z-0788-2014 · Posted 2014-01-23

Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeKGG
Date Initiated2013-10-11
Date Terminated2015-07-28
Product Quantity3,860

Reason for Recall

Incorrect instructions for use (IFU).

Firm Action

The firm, CODMAN Neuro, sent a "Medical Device Correction Notice" letter dated October 21, 2013 to its consignees/customers. The letter describes the product, problem and actions taken. The letter informed the consignees/customers of the incorrect statement in the IFU. The Corrected IFU was provided. Codman Neuro is in the process of updating the Instructions for Use to include the corrected information. Consignees/customers were instructed to complete and return the Correction Notice Acknowledgement Form and fax it to Codman Neuro at 508-977-6665. For additional information, please contact Codman Neuro representative at 1-866-491-0974.

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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