Device recall
Z-1343-2009: Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1343-2009 |
|---|---|
| Recall event | 51334 |
| Product | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001231360 IE TEMP TIP 8/22 M001231370 IE TEMP TIP 8/24 M001231380 IE TEMP TIP 8/26 M001231390 IE TEMP TIP 8/28 M001231400 IE TEMP TIP 10/22 M001231410 IE TEMP TIP 10/24 M001231420 IE TEMP TIP 10/26… |
| 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