TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and

FDA device recall Z-0789-2014 · posted 2014-01-23 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

Incorrect instructions for use (IFU).

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.

Root cause

Employee error

Status

Terminated

Product code

KGG

Quantity affected

7,983

Distribution

Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.

Date initiated

2013-10-11

Date posted

2014-01-23

Date terminated

2015-07-28

Location

Raynham, MA