Device recall
Z-1344-2009: Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1344-2009 |
|---|---|
| Recall event | 51334 |
| Product | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M0064102020 Percuflex All Purpose Drainage Catheters wit Fader Tip and Locking Pigtail 8 Fr M0064102030 Percuflex All Purpose Drainage Catheters with Fader Tip and Locking Pigtail 10 Fr Single Use… |
| Product code | FGE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2012 |
| 510(k) numbers | K900205 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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