Recall Z-0788-2014— Codman & Shurtleff, Inc.
Class I · Terminated
Class I FDA medical device recall by Codman & Shurtleff, Inc., initiated 2013-10-11, terminated 2015-07-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Incorrect instructions for use (IFU)..
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-10-11
- Terminated
- 2015-07-28
- Firm location
- Raynham, MA, United States
Product description
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.
Reason for recall
Incorrect instructions for use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.