Device recall
Z-0788-2014: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of…
FDA device recall · Class I · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-0788-2014 |
|---|---|
| Recall event | 66493 |
| 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)… |
| Product code | KGG |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 28, 2015 |
| PMA numbers | P990040 |
| FEI number | 3002947440 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database