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.
This recall has been terminated (originally issued January 23, 2014).
- Company
- Codman & Shurtleff, Inc.
- Recall Initiated
- October 11, 2013
- Posted
- January 23, 2014
- Terminated
- July 28, 2015
- Recall Number
- Z-0788-2014
- Quantity
- 3,860
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect instructions for use (IFU).
Distribution
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
Lot / Code Info
All lot codes
Root Cause
Employee error
Action Taken
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.