Codman & Shurtleff, Inc. recalls TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil a

Recalled January 29, 2014 · FDA recall Z-0789-2014 · Codman & Shurtleff

Hazard

Incorrect instructions for use (IFU). · FDA Class I

Units

7,983

Sold at

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

Description

Incorrect instructions for use (IFU).

Product

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.

Manufacturer(s)

Codman & Shurtleff, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →