Recall Z-0788-2014 ยท KGG Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
Codman & Shurtleff, Inc.
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.
| Date | Jan 23, 2014 (initiated Oct 11, 2013) |
| Status | Terminated |
| Reason | Incorrect instructions for use (IFU). |
| Root cause | Employee error |
| Action | 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 |
| Quantity | 3,860 |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.