Home / Recalls / Codman & Shurtleff, Inc. / Z-0788-2014

Z-0788-2014 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
3,860

Product Description

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.

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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