Codman & Shurtleff, Inc. Recall: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Sys
Codman & Shurtleff, Inc. Recall: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Sys is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Codman & Shurtleff, Inc.; Product: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodize
| Recalling firm | Codman & Shurtleff, Inc. |
|---|---|
| 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. |
| Reason for recall | Incorrect instructions for use (IFU). |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia. |
| Recall initiated | 20131011 |
| Recall number | Z-0789-2014 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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