Recall Z-0789-2014
Codman & Shurtleff, Inc. · initiated October 11, 2013
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: All lot codes
Reason for recall
Incorrect instructions for use (IFU).
FDA-determined 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.
Details
- Recall number
- Z-0789-2014
- Initiated
- October 11, 2013
- Posted by FDA
- January 23, 2014
- Terminated
- July 28, 2015
- Product code
- KGG – Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- Quantity
- 7,983
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0788-2014 Class I | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one…Incorrect instructions for use (IFU). | 10/11/2013Terminated |