FDAFDA · Food and drugs·Recall number Z-0789-2014
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.
Published January 29, 2014 · Recall initiated: October 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect instructions for use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
- Lot
- All lot codes
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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