Home / Recalls / Codman & Shurtleff, Inc. / Z-0789-2014

Z-0789-2014 Class I Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
January 29, 2014
Initiation Date
October 11, 2013
Termination Date
July 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,983

Product Description

TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

Reason for Recall

Incorrect instructions for use (IFU).

Distribution Pattern

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

Code Information

All lot codes

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