Date Initiated by Firm | October 11, 2013 |
Date Posted | January 23, 2014 |
Recall Status1 |
Terminated 3 on July 28, 2015 |
Recall Number | Z-0788-2014 |
Recall Event ID |
66493 |
PMA Number | P990040 |
Product Classification |
tissue adhesive for use in embolization of brain arteriovenous malformations - Product Code KGG
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Product | 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. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham MA 02767
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For Additional Information Contact | 866-491-0974 |
Manufacturer Reason for Recall | Incorrect instructions for use (IFU). |
FDA Determined Cause 2 | 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 Codman Neuro representative at 1-866-491-0974. |
Quantity in Commerce | 3,860 |
Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = KGG
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